Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-2P)

February 29, 2024 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Study Overview

Status

Active, not recruiting

Detailed Description

Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Study Type

Interventional

Enrollment (Actual)

17013

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1428DCO
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1430EGF
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1425AGP
        • Novartis Investigative Site
      • Ciudad de Buenos Aires, Argentina, C1426
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KET
        • Novartis Investigative Site
      • Cordoba, Argentina, X5002
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400
        • Novartis Investigative Site
      • Formosa, Argentina, P3600
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FWO
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EOZ
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1280AEB
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1056ABJ
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1221ADC
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1405BCH
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1187
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1119ACN
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Novartis Investigative Site
      • Ramos Mejia, Buenos Aires, Argentina, B1704ETD
        • Novartis Investigative Site
      • San Martin, Buenos Aires, Argentina, B1650CSQ
        • Novartis Investigative Site
    • Misiones
      • Posadas, Misiones, Argentina, N3300
        • Novartis Investigative Site
    • Provincia De Salta
      • Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
        • Novartis Investigative Site
    • San Miguel De Tucuman
      • Tucuman, San Miguel De Tucuman, Argentina, T4000ICL
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, 2000
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S200CVD
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
        • Novartis Investigative Site
      • Richmond, Australia, 3121
        • Novartis Investigative Site
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Novartis Investigative Site
      • Liverpool, New South Wales, Australia, 2170
        • Novartis Investigative Site
      • New Lambton Heights, New South Wales, Australia, 2305
        • Novartis Investigative Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Novartis Investigative Site
      • Bundaberg West, Queensland, Australia, 4670
        • Novartis Investigative Site
      • Milton, Queensland, Australia, 4064
        • Novartis Investigative Site
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
      • Bedford Park, South Australia, Australia, 5042
        • Novartis Investigative Site
      • Leabrook, South Australia, Australia, 5068
        • Novartis Investigative Site
      • Woodville, South Australia, Australia, 5011
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Geelong, Victoria, Australia, 3220
        • Novartis Investigative Site
      • Malvern East, Victoria, Australia, 3145
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Novartis Investigative Site
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
      • Braunau, Austria, A5280
        • Novartis Investigative Site
      • Graz, Austria, A-8036
        • Novartis Investigative Site
      • Wien, Austria, 1090
        • Novartis Investigative Site
      • Antwerpen, Belgium, 2020
        • Novartis Investigative Site
      • Brasschaat, Belgium, 2930
        • Novartis Investigative Site
      • Brugge, Belgium, 8000
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1020
        • Novartis Investigative Site
      • Charleroi, Belgium, 6000
        • Novartis Investigative Site
      • Edegem, Belgium, 2650
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Kortrijk, Belgium, 8500
        • Novartis Investigative Site
      • La Louviere, Belgium, 7100
        • Novartis Investigative Site
      • Roeselare, Belgium, 8800
        • Novartis Investigative Site
      • Ronse, Belgium, 9600
        • Novartis Investigative Site
      • Yvoir, Belgium, 5530
        • Novartis Investigative Site
      • Campinas, Brazil, 13092-133
        • Novartis Investigative Site
      • Rio de Janeiro, Brazil, 20241-180
        • Novartis Investigative Site
      • Sao Jose, Brazil, 8001
        • Novartis Investigative Site
      • Sao Paulo, Brazil, 04026-090
        • Novartis Investigative Site
    • AL
      • Maceio, AL, Brazil, 57051-160
        • Novartis Investigative Site
    • BA
      • Salvador, BA, Brazil, 40170-130
        • Novartis Investigative Site
    • DF
      • Brasilia, DF, Brazil, 70390-903
        • Novartis Investigative Site
      • Brasilia, DF, Brazil, 71625-009
        • Novartis Investigative Site
    • ES
      • Vitoria, ES, Brazil, 29055-450
        • Novartis Investigative Site
    • MG
      • Belo Horizonte, MG, Brazil, 30220330
        • Novartis Investigative Site
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 38400 500
        • Novartis Investigative Site
    • PR
      • Curitiba, PR, Brazil, 80730-150
        • Novartis Investigative Site
    • RS
      • Pelotas, RS, Brazil, 96015-290
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90880-480
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90160093
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90560 030
        • Novartis Investigative Site
    • SE
      • Aracaju, SE, Brazil, 49055530
        • Novartis Investigative Site
    • SP
      • Campinas, SP, Brazil, 13060 080
        • Novartis Investigative Site
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Novartis Investigative Site
      • Santo Andre, SP, Brazil, 09060-870
        • Novartis Investigative Site
      • Santo Andre, SP, Brazil, 09090-790
        • Novartis Investigative Site
      • Sao Bernardo do Campo, SP, Brazil, 09715 090
        • Novartis Investigative Site
      • Sao Jose do Rio Preto, SP, Brazil, 15015-750
        • Novartis Investigative Site
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 05403 000
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 04005-003
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 04266 010
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 01323-903
        • Novartis Investigative Site
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89020 430
        • Novartis Investigative Site
    • Sao Paulo
      • Santo Andre, Sao Paulo, Brazil, 09030-010
        • Novartis Investigative Site
      • Blagoevgrad, Bulgaria, 270 0
        • Novartis Investigative Site
      • Burgas, Bulgaria, 8000
        • Novartis Investigative Site
      • Haskovo, Bulgaria, 6300
        • Novartis Investigative Site
      • Kyustendil, Bulgaria, 2500
        • Novartis Investigative Site
      • Montana, Bulgaria, 3400
        • Novartis Investigative Site
      • Pernik, Bulgaria, 2300
        • Novartis Investigative Site
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4000
        • Novartis Investigative Site
      • Ruse, Bulgaria, 7000
        • Novartis Investigative Site
      • Ruse, Bulgaria, 7012
        • Novartis Investigative Site
      • Sliven, Bulgaria, 8800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1527
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1113
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1407
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1202
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1709
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1000
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1784
        • Novartis Investigative Site
      • Stamboliyski, Bulgaria, 4210
        • Novartis Investigative Site
      • Stara Zagora, Bulgaria, 6000
        • Novartis Investigative Site
      • Stara Zagora, Bulgaria, 6003
        • Novartis Investigative Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Novartis Investigative Site
    • Blagoevgrad
      • Sandanski, Blagoevgrad, Bulgaria, 2850
        • Novartis Investigative Site
      • Quebec, Canada, G1W 4R4
        • Novartis Investigative Site
      • Quebec, Canada, G2J 0C4
        • Novartis Investigative Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T5H 4B9
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T6K 4C1
        • Novartis Investigative Site
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7M 2H4
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novartis Investigative Site
      • Victoria, British Columbia, Canada, V8R4R2
        • Novartis Investigative Site
      • Victoria, British Columbia, Canada, V8T 5G4
        • Novartis Investigative Site
      • Victoria, British Columbia, Canada, V8V 4A1
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Novartis Investigative Site
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • Novartis Investigative Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Novartis Investigative Site
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Novartis Investigative Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Novartis Investigative Site
      • Guelph, Ontario, Canada, N1H 1B1
        • Novartis Investigative Site
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Novartis Investigative Site
      • Oakville, Ontario, Canada, L6K 3W7
        • Novartis Investigative Site
      • Peterborough, Ontario, Canada, K9J 0B2
        • Novartis Investigative Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Novartis Investigative Site
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Novartis Investigative Site
      • Scarborough, Ontario, Canada, M1B 5N1
        • Novartis Investigative Site
      • Stoufville, Ontario, Canada, L4A 1H2
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3M 1L3
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Novartis Investigative Site
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Novartis Investigative Site
      • Sainte Foy, Quebec, Canada, G1V 4G2
        • Novartis Investigative Site
      • St Jerome, Quebec, Canada, J7Z 5T3
        • Novartis Investigative Site
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Novartis Investigative Site
      • Trois Rivieres, Quebec, Canada, G8Z 3R9
        • Novartis Investigative Site
      • Santiago, Chile, 7500710
        • Novartis Investigative Site
      • Santiago, Chile, 838 0456
        • Novartis Investigative Site
    • Araucania
      • Victoria, Araucania, Chile, 4720097
        • Novartis Investigative Site
    • Los Lagos
      • Osorno, Los Lagos, Chile, 5311092
        • Novartis Investigative Site
    • RM
      • Santiago, RM, Chile, 8380465
        • Novartis Investigative Site
    • Region De Coquimbo
      • La Serena, Region De Coquimbo, Chile, 1720430
        • Novartis Investigative Site
    • Region De La Araucania
      • Temuco, Region De La Araucania, Chile, 4781156
        • Novartis Investigative Site
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8331143
        • Novartis Investigative Site
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2520997
        • Novartis Investigative Site
      • Beijing, China, 100029
        • Novartis Investigative Site
      • Beijing, China, 100034
        • Novartis Investigative Site
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Beijing, China, 100191
        • Novartis Investigative Site
      • Beijing, China, 100039
        • Novartis Investigative Site
      • Guang Zhou, China, 510080
        • Novartis Investigative Site
      • Guangzhou, China, 510280
        • Novartis Investigative Site
      • Jinan, China, 250012
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
      • Tianjin, China, 300140
        • Novartis Investigative Site
      • Xiamen, China, 361004
        • Novartis Investigative Site
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Novartis Investigative Site
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 51000
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510515
        • Novartis Investigative Site
      • Guangzhou City, Guangdong, China, 510000
        • Novartis Investigative Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Novartis Investigative Site
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430060
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430022
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430014
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Novartis Investigative Site
      • Changsha, Hunan, China, 410003
        • Novartis Investigative Site
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010017
        • Novartis Investigative Site
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • Novartis Investigative Site
      • Jiangyin, Jiangsu, China, 214499
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210008
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210009
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 211166
        • Novartis Investigative Site
      • Suzhou, Jiangsu, China, 215006
        • Novartis Investigative Site
      • Xuzhou, Jiangsu, China, 221003
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novartis Investigative Site
      • Pingxiang, Jiangxi, China, 337000
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novartis Investigative Site
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Novartis Investigative Site
      • Shenyang, Liaoning, China, 110003
        • Novartis Investigative Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Novartis Investigative Site
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Novartis Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030002
        • Novartis Investigative Site
      • Xian, Shanxi, China, 710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Novartis Investigative Site
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Novartis Investigative Site
      • Wulumuqi, Xinjiang, China, 830054
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Novartis Investigative Site
      • Lishui City, Zhejiang, China, 323000
        • Novartis Investigative Site
      • Taizhou, Zhejiang, China, 318000
        • Novartis Investigative Site
      • Barranquilla, Colombia, 080020
        • Novartis Investigative Site
      • Bogota, Colombia, 110221
        • Novartis Investigative Site
      • Cali, Colombia, 760024
        • Novartis Investigative Site
      • Florida Blanca, Colombia, 681001
        • Novartis Investigative Site
    • Antioquia
      • Medellin, Antioquia, Colombia, 050036
        • Novartis Investigative Site
      • Medellin, Antioquia, Colombia, 050021
        • Novartis Investigative Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080002
        • Novartis Investigative Site
    • Bolivar
      • Cartagena, Bolivar, Colombia, 130001
        • Novartis Investigative Site
    • Caldas
      • Manizales, Caldas, Colombia, 1700
        • Novartis Investigative Site
    • Risaralda
      • Pereira, Risaralda, Colombia, 660003
        • Novartis Investigative Site
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760001
        • Novartis Investigative Site
      • Cali, Valle Del Cauca, Colombia, 760032
        • Novartis Investigative Site
      • Cakovec, Croatia, 40000
        • Novartis Investigative Site
      • Krapinske toplice, Croatia, 49 217
        • Novartis Investigative Site
      • Opatija, Croatia, 51410
        • Novartis Investigative Site
      • Osijek, Croatia, 31000
        • Novartis Investigative Site
      • Rijeka, Croatia, 51000
        • Novartis Investigative Site
      • Slavonski Brod, Croatia, 35000
        • Novartis Investigative Site
      • Split, Croatia, 21000
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Novartis Investigative Site
      • Bedihost, Czechia, 798 21
        • Novartis Investigative Site
      • Brno, Czechia, 638 00
        • Novartis Investigative Site
      • Brno Bohunice, Czechia, 625 00
        • Novartis Investigative Site
      • Hodonin, Czechia, 69501
        • Novartis Investigative Site
      • Hradec Kralove, Czechia, 500 05
        • Novartis Investigative Site
      • JIhlava, Czechia, 586 01
        • Novartis Investigative Site
      • Marianske lazne, Czechia, 353 01
        • Novartis Investigative Site
      • Nachod, Czechia, 547 01
        • Novartis Investigative Site
      • Ostrava, Czechia, 70030
        • Novartis Investigative Site
      • Ostrava, Czechia, 71000
        • Novartis Investigative Site
      • Ostrava, Czechia, 728 80
        • Novartis Investigative Site
      • Pardubice, Czechia, 532 03
        • Novartis Investigative Site
      • Praha, Czechia, 120 00
        • Novartis Investigative Site
      • Praha 10, Czechia, 100 34
        • Novartis Investigative Site
      • Praha 5, Czechia, 158 00
        • Novartis Investigative Site
      • Prerov, Czechia, 751 52
        • Novartis Investigative Site
      • Pribram VIII, Czechia, 261 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czechia, 68601
        • Novartis Investigative Site
      • Zlin, Czechia, 76001
        • Novartis Investigative Site
    • CZE
      • Policska, CZE, Czechia, 57201
        • Novartis Investigative Site
    • Czech Republic
      • Brno, Czech Republic, Czechia, 656 91
        • Novartis Investigative Site
      • Brno, Czech Republic, Czechia, 60200
        • Novartis Investigative Site
      • Cesky Krumlov, Czech Republic, Czechia, 381 01
        • Novartis Investigative Site
      • Louny, Czech Republic, Czechia, 440 01
        • Novartis Investigative Site
      • Slany, Czech Republic, Czechia, 27401
        • Novartis Investigative Site
      • Svitavy, Czech Republic, Czechia, 568 25
        • Novartis Investigative Site
      • Trebic, Czech Republic, Czechia, 674 01
        • Novartis Investigative Site
      • Arhus C, Denmark, DK 8000
        • Novartis Investigative Site
      • Esbjerg, Denmark, DK-6700
        • Novartis Investigative Site
      • Glostrup, Denmark, 2600
        • Novartis Investigative Site
      • Herlev, Denmark, 2730
        • Novartis Investigative Site
      • Hjorring, Denmark, DK-9800
        • Novartis Investigative Site
      • Roskilde, Denmark, 4000
        • Novartis Investigative Site
      • Svendborg, Denmark, 5700
        • Novartis Investigative Site
      • Viborg, Denmark, DK-8800
        • Novartis Investigative Site
    • Central Jutland
      • Herning, Central Jutland, Denmark, DK-7400
        • Novartis Investigative Site
      • Parnu, Estonia, 80018
        • Novartis Investigative Site
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tallinn, Estonia, 13619
        • Novartis Investigative Site
      • Tallinn, Estonia, 10117
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Novartis Investigative Site
      • Tartu, Estonia, 50708
        • Novartis Investigative Site
      • Helsinki, Finland, 00180
        • Novartis Investigative Site
      • Jyvaskyla, Finland, 40620
        • Novartis Investigative Site
      • Turku, Finland, 20520
        • Novartis Investigative Site
      • Turku, Finland, 20100
        • Novartis Investigative Site
    • Pohjois Savo
      • Kuopio, Pohjois Savo, Finland, 70211
        • Novartis Investigative Site
      • Amiens, France, 80054
        • Novartis Investigative Site
      • Beziers Cedex, France, 34525
        • Novartis Investigative Site
      • Brest, France, 29200
        • Novartis Investigative Site
      • Chambray les Tours, France, 37170
        • Novartis Investigative Site
      • Cholet, France, 49325
        • Novartis Investigative Site
      • Clermont Ferrand, France, 63000
        • Novartis Investigative Site
      • Corbeil Essonnes, France, 91100
        • Novartis Investigative Site
      • Grenoble Cedex 9, France, 38043
        • Novartis Investigative Site
      • Le Coudray, France, 28630
        • Novartis Investigative Site
      • Lille, France, 59037
        • Novartis Investigative Site
      • Lille, France, 59042
        • Novartis Investigative Site
      • Limoges cedex, France, 87042
        • Novartis Investigative Site
      • Marseille, France, 13008
        • Novartis Investigative Site
      • Marseille Cedex 05, France, 13885
        • Novartis Investigative Site
      • Metz, France, 57085
        • Novartis Investigative Site
      • Montauban, France, 82017
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Nimes Cedex 09, France, 30029
        • Novartis Investigative Site
      • Orleans, France, 45100
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris, France, 75018
        • Novartis Investigative Site
      • Paris 13, France, 75651
        • Novartis Investigative Site
      • Paris cedex 10, France, 75010
        • Novartis Investigative Site
      • Pau Cedex, France, 64046
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      • Ioannina, GR, Greece, 455 00
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      • Seoul, Korea, Republic of, 03722
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      • Phoenix, Mauritius, 73408
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      • Xalapa, Mexico, 91020
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      • Xalapa, Mexico, 91193
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      • Alkmaar, Netherlands, 1815 JD
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      • Arendal, Norway, 4838
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      • Drammen, Norway, 3004
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      • Oslo, Norway, NO 0450
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      • Oslo, Norway, 0514
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      • Skedsmokorset, Norway, 2020
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      • Quezon, Philippines, 1102
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      • Krakow, Poland, 30-363
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      • Torun, Poland, 87100
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      • Bayamon, Puerto Rico, 00961
        • Bayamon Health Center
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc Centro Med Episcopal San Lucas
      • Ponce, Puerto Rico, 00717-1322
        • Research and Cardiovascular Corp
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center Inc Research
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        • Latin Clinical Trial Center Inc
      • San Juan, Puerto Rico, 00926
        • Advanced Medical Research Center .
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      • Baia Mare, Romania, 430123
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      • Bucharest, Romania, 050098
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      • Bucharest, Romania, 021659
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      • Bucuresti, Romania, 022328
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      • Bucuresti, Romania, 011461
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      • Bucuresti, Romania, 11025
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      • Craiova, Romania, 200642
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      • Targu Mures, Romania, 540143
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      • Timisoara, Romania, 300359
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      • Timisoara, Timis, Romania, 300480
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      • Belgrade, Serbia, 11 000
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      • Belgrade, Serbia, 11070
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      • Belgrade, Serbia, 11080
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      • Cuprija, Serbia, 35230
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      • Kragujevac, Serbia, 34000
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      • Nis, Serbia, 18000
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      • Smederevo, Serbia, 26000
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      • Sremska Kamenica, Serbia, 21204
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      • Subotica, Serbia, 24000
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      • Vranje, Serbia, 17500
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      • Singapore, Singapore, 529889
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      • Singapore, Singapore, 169609
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      • Singapore, Singapore, 768828
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      • Singapore, Singapore, 117549
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      • Bardejov, Slovakia, 085 01
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      • Bardejov, Slovakia, 08501
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      • Bratislava, Slovakia, 833 48
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      • Bratislava, Slovakia, 841 07
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      • Bratislava, Slovakia, 85101
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      • Bratislava, Slovakia, 813 69
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      • Bratislava, Slovakia, 83106
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      • Kosice, Slovakia, 040 01
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      • Lucenec, Slovakia, 98439
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      • Moldava nad Bodvou, Slovakia, 04501
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      • Nitra, Slovakia, 949 01
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      • Nove Zamky, Slovakia, 940 01
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      • Piestany, Slovakia, 921 01
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      • Povazska Bystrica, Slovakia, 01701
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      • Presov, Slovakia, 080 01
        • Novartis Investigative Site
      • Roznava, Slovakia, 048 01
        • Novartis Investigative Site
    • SVK
      • Banska Bystrica, SVK, Slovakia, 974 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 826 06
        • Novartis Investigative Site
      • Bratislava, Slovak Republic, Slovakia, 851 01
        • Novartis Investigative Site
      • Kosice, Slovak Republic, Slovakia, 040 22
        • Novartis Investigative Site
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site
    • Zilinsky Kraj
      • Zilina, Zilinsky Kraj, Slovakia, 010 01
        • Novartis Investigative Site
      • Celje, Slovenia, 3000
        • Novartis Investigative Site
      • Ljubljana, Slovenia, 1000
        • Novartis Investigative Site
      • Ptuj, Slovenia, 2250
        • Novartis Investigative Site
      • Slovenj Gradec, Slovenia, 2380
        • Novartis Investigative Site
      • Bloemfontein, South Africa, 9301
        • Novartis Investigative Site
      • Cape Town, South Africa, 7500
        • Novartis Investigative Site
      • Midrand, South Africa, 1685
        • Novartis Investigative Site
      • Pretoria, South Africa, 0181
        • Novartis Investigative Site
      • Worcester, South Africa, 6850
        • Novartis Investigative Site
    • Centurion
      • Raslouw, Centurion, South Africa, 157
        • Novartis Investigative Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novartis Investigative Site
    • Gauteng
      • Germiston, Gauteng, South Africa, 1401
        • Novartis Investigative Site
      • Pretoria, Gauteng, South Africa, 0184
        • Novartis Investigative Site
      • Pretoria, Gauteng, South Africa, 0002
        • Novartis Investigative Site
      • Soweto, Gauteng, South Africa, 2013
        • Novartis Investigative Site
      • Vereeniging, Gauteng, South Africa, 1939
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Novartis Investigative Site
      • Cape Town, Western Cape, South Africa, 7130
        • Novartis Investigative Site
      • George, Western Cape, South Africa, 6529
        • Novartis Investigative Site
      • Paarl, Western Cape, South Africa, 7626
        • Novartis Investigative Site
    • ZAF
      • Cape Town, ZAF, South Africa, 7570
        • Novartis Investigative Site
      • A Coruna, Spain, 15001
        • Novartis Investigative Site
      • Alicante, Spain, 03700
        • Novartis Investigative Site
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Barcelona, Spain, 08025
        • Novartis Investigative Site
      • Granada, Spain, 18016
        • Novartis Investigative Site
      • Huelva, Spain, 21007
        • Novartis Investigative Site
      • Las Palmas de Gran Canaria, Spain, 35010
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
      • Madrid, Spain, 28003
        • Novartis Investigative Site
      • Salamanca, Spain, 37005
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
    • A Coruna
      • Ferrol, A Coruna, Spain, 15405
        • Novartis Investigative Site
    • Andalucia
      • Almeria, Andalucia, Spain, 04009
        • Novartis Investigative Site
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
      • Jerez de la Frontera, Andalucia, Spain, 11407
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41014
        • Novartis Investigative Site
      • Utrera, Andalucia, Spain, 41710
        • Novartis Investigative Site
    • Barcelona
      • El Prat de Llobregat, Barcelona, Spain, 08820
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
      • Sant Joan Despi, Barcelona, Spain, 08970
        • Novartis Investigative Site
    • Cadiz
      • Villamartin, Cadiz, Spain, 11650
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Novartis Investigative Site
      • Valladolid, Castilla Y Leon, Spain, 47011
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08024
        • Novartis Investigative Site
      • Reus, Cataluna, Spain, 43201
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Novartis Investigative Site
    • Galicia
      • A Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
      • La Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
      • Santiago De Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
    • Islas Baleares
      • Mallorca, Islas Baleares, Spain, 07198
        • Novartis Investigative Site
      • Palma De Mallorca, Islas Baleares, Spain, 07120
        • Novartis Investigative Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Novartis Investigative Site
      • San Sebastian de los Reyes, Madrid, Spain, 28702
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
        • Novartis Investigative Site
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36212
        • Novartis Investigative Site
      • Falun, Sweden, 791 82
        • Novartis Investigative Site
      • Goteborg, Sweden, SE-412 55
        • Novartis Investigative Site
      • Lund, Sweden, 221 85
        • Novartis Investigative Site
      • Malmo, Sweden, 214 28
        • Novartis Investigative Site
      • Stockholm, Sweden, 111 57
        • Novartis Investigative Site
      • Stockholm, Sweden, 17176
        • Novartis Investigative Site
      • Vasteras, Sweden, 721 89
        • Novartis Investigative Site
    • SE
      • Stockholm, SE, Sweden, 141 86
        • Novartis Investigative Site
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sweden, 416 85
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 80756
        • Novartis Investigative Site
      • Tainan, Taiwan, 70403
        • Novartis Investigative Site
      • Tainan, Taiwan, 71004
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
      • Taipei, Taiwan, 110
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Muang, Thailand, 40002
        • Novartis Investigative Site
      • Muang, Thailand, 12120
        • Novartis Investigative Site
    • Songkla
      • Hat Yai, Songkla, Thailand, 90110
        • Novartis Investigative Site
      • Adana, Turkey, 01160
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Bursa, Turkey, 16140
        • Novartis Investigative Site
      • Cerrahpasa/Istanbul, Turkey, 34303
        • Novartis Investigative Site
      • Diskapi / Ankara, Turkey, 06110
        • Novartis Investigative Site
      • Istanbul, Turkey, 34865
        • Novartis Investigative Site
      • Istanbul, Turkey, 34147
        • Novartis Investigative Site
      • Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Konya, Turkey, 42080
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Novartis Investigative Site
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group LLC
      • Birmingham, Alabama, United States, 35211
        • Ascension St Vincent's .
      • Fairhope, Alabama, United States, 36532
        • Eastern Shore Research Group, LLC
      • Foley, Alabama, United States, 36535
        • G and L Research LLC
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Cardiology Reserach Foundation, NFP
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Heart Group Deer Valley .
      • Sun City West, Arizona, United States, 85375
        • Clinical Research Inst of Arizona
      • Tucson, Arizona, United States, 85704
        • Pima Heart And Vascular Clin Rch .
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Clinical Research
      • Little Rock, Arkansas, United States, 72205
        • ARcare Center for Clinical Research
      • Little Rock, Arkansas, United States, 72205
        • ARcare Center for Clinical Research .
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Center
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research .
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research Center
      • Fresno, California, United States, 93720
        • The Heart Group Cardiovascular Associates Inc
      • Fullerton, California, United States, 92835
        • Ascada Research
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management Center
      • Irvine, California, United States, 92660
        • University of Calif Irvine Med Cntr
      • La Jolla, California, United States, 92037
        • UC San Diego Health Altman Clin Trnsltnl Res Inst
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Los Angeles, California, United States, 90033
        • Keck Medical Center USC Keck School of Medicine of USC
      • Oxnard, California, United States, 93030
        • Cabrillo Cardiology Medical Group
      • Palo Alto, California, United States, 94304-1207
        • VA Palo Alto Health Care System .
      • San Diego, California, United States, 92161
        • San Diego Veterans Medical Center
      • San Ramon, California, United States, 94582
        • West Coast Research LLC .
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Santa Ana, California, United States, 92704
        • Helping Hands Medical Associates, INC
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research .
      • Stanford, California, United States, 94304
        • Stanford University Medical Center School of Medicine
      • Stockton, California, United States, 95204
        • Manshadi Heart Institute
      • Torrance, California, United States, 90502
        • University of California at Los Angeles
      • Tustin, California, United States, 92780
        • Tilda Research
      • Vista, California, United States, 92083
        • Blue Coast Research Center LLC
      • West Hills, California, United States, 91307
        • Interventional Cardiology Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Med Ctr
      • Denver, Colorado, United States, 80218
        • Aurora Denver Cardiology Associates
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Greenwich, Connecticut, United States, 06830
        • d-b-a Greenwich Cardio Assoc
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center Medstar
      • Washington, District of Columbia, United States, 20020
        • Emerson Clinical Research Institute, LLC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials LLC
      • Bradenton, Florida, United States, 34209
        • Cardiovascular and Vein Center of Florida
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research LLC .
      • Clearwater, Florida, United States, 33756
        • Bay Care Medical Group
      • Daytona Beach, Florida, United States, 32117
        • Cardiology Research Associates
      • DeLand, Florida, United States, 32720
        • Hillcrest Medical Research
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Ctr Inc
      • Hialeah, Florida, United States, 33013
        • Inpatient Research Clinical LLC
      • Hialeah, Florida, United States, 33013
        • National Research Institute
      • Hollywood, Florida, United States, 33024
        • Cano Research
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research .
      • Jacksonville, Florida, United States, 32209-6511
        • University of Florida - Shands Jacksonville UF Health Jacksonville
      • Jacksonville Beach, Florida, United States, 32050
        • Baptist Heart Specialists
      • Lake Worth, Florida, United States, 33461
        • United Vein and Vascular Centers
      • Miami, Florida, United States, 33133
        • Infinite Clinical Research
      • Miami, Florida, United States, 33186
        • A&A Research Group Inc
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research
      • Miami Lakes, Florida, United States, 33014
        • RM Medical Research Inc
      • Miramar, Florida, United States, 33027
        • Eminat LLC
      • Naples, Florida, United States, 34102
        • Advanced Research for Health Improvement LLC
      • Ocala, Florida, United States, 34471
        • Ocala Cardiovascular Research
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research
      • Palm Springs, Florida, United States, 33406
        • CTMD Research
      • Pembroke Pines, Florida, United States, 33024
        • Broward Research Center
      • Pensacola, Florida, United States, 32501
        • SEC Clinical Research
      • Port Charlotte, Florida, United States, 33952
        • Peace River Cardiovascular Center
      • Saint Petersburg, Florida, United States, 33713
        • Advanced Medical Research Center
      • Tampa, Florida, United States, 33614
        • BayCare Medical Group Inc
      • Tampa, Florida, United States, 33614
        • Genesis Clinical Research
      • Tampa, Florida, United States, 33603
        • New Tampa Health
      • Tampa, Florida, United States, 33612
        • James A Haley Veterans Hospital .
      • Tampa, Florida, United States, 33705
        • BayCare Health System .
      • Tampa, Florida, United States, 33880
        • Ravessa Clinical Research
      • Wellington, Florida, United States, 33449
        • Cardiology Partners Clinical Research Institute
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • APRC, Inc
      • Fayetteville, Georgia, United States, 30214
        • Javara Research .
      • Fayetteville, Georgia, United States, 30214
        • Javara Research South Coast Health
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Tucker, Georgia, United States, 30084
        • Atlanta Heart Specialists LLC Main Center
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
      • Nampa, Idaho, United States, 83686
        • Saltzer Health
    • Illinois
      • Addison, Illinois, United States, 60101
        • Biofortis Research
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research LLC
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute Inc
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Ct
      • Jerseyville, Illinois, United States, 62052
        • Gateway Cardiology PC
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Springfield, Illinois, United States, 62702
        • SIU School of Medicine
      • Springfield, Illinois, United States, 62769
        • Prairie Heart Institute
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Elkhart Cardiology Group
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Services Research Center .
      • Lebanon, Indiana, United States, 46052
        • Witham Health Services
      • Merrillville, Indiana, United States, 46410
        • The Heart Center of Lake County
      • Munster, Indiana, United States, 46321
        • Cardiovascular Research of Northwest Indiana, LLC
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Covenant Medical Center MercyOne Waterloo Med Ct
    • Kansas
      • Kansas City, Kansas, United States, 66160-7330
        • University of Kansas Medical Center .
      • Overland Park, Kansas, United States, 66209
        • Midwest Heart and Vascular Spec
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Research .
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky College of Health Sciences .
      • Louisville, Kentucky, United States, 40202
        • U of Louisville Rudd Heart and Lung .
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Baton Rouge, Louisiana, United States, 70808
        • Louisiana Cardiology Associates
      • Bossier City, Louisiana, United States, 71111
        • Grace Research Llc
      • Covington, Louisiana, United States, 70433
        • Cardiovascular Associates Research Main Center
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC Clinical Trials Mgmt-Covington
      • Crowley, Louisiana, United States, 70526
        • Avant Research Associates LLC
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas, LLC
      • Gray, Louisiana, United States, 70359
        • Cardiovascular Institute South ASC
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond
      • Hammond, Louisiana, United States, 70403
        • Louisiana Heart Center Research
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South Dept of Cardiovascular Inst
      • Lafayette, Louisiana, United States, 70506
        • Cardiovascular Institute of the South
      • Mandeville, Louisiana, United States, 70448
        • North Shore Heart and Vascular
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Management, LLC .
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America LA LLC
      • Natchitoches, Louisiana, United States, 71457
        • Barnum Medical Research Inc
      • New Orleans, Louisiana, United States, 70115
        • Crescent City Physicians Inc
      • Opelousas, Louisiana, United States, 70570
        • Cardiovascular Institute of the South
      • Shreveport, Louisiana, United States, 71105
        • Grace Research Llc
      • Slidell, Louisiana, United States, 70458
        • Louisiana Heart Center Research
      • Zachary, Louisiana, United States, 70791
        • Southern Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Sinai Ct for Throm Res and Drug Dev
      • Beltsville, Maryland, United States, 20705
        • Metropolitan Cardiovascular Consultants Llc
      • Columbia, Maryland, United States, 21044
        • Johns Hopkins University
      • Fort Washington, Maryland, United States, 20744
        • Anderson Medical Research Main Center
      • Glenn Dale, Maryland, United States, 20769
        • Javara Inc .
      • Lanham, Maryland, United States, 20706
        • Capitol Cardiology Associates
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
      • Rockville, Maryland, United States, 20850
        • Adventist HealthCare Shady Grove Medical Center
      • Salisbury, Maryland, United States, 21804
        • Tidal Health Peninsula Regional Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center Main Centre
      • Boston, Massachusetts, United States, 02132
        • VA Boston Healthcare System Jamaica Plain Division
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Ce .
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Flint, Michigan, United States, 48504
        • AA Medical Research Center
      • Grand Rapids, Michigan, United States, 49546
        • Healthy Heart Cardiology
      • Lansing, Michigan, United States, 48910
        • Mclaren Greater Lansing
      • Midland, Michigan, United States, 48640
        • MidMichigan Medical Center Midland Main Center
      • Saginaw, Michigan, United States, 48601
        • Ascension St Marys Hospital
      • Southfield, Michigan, United States, 48075
        • Providence Hospital Patient Care Research
      • Traverse City, Michigan, United States, 49684
        • Traverse Heart and Vascular
      • Wyoming, Michigan, United States, 49519
        • Metro Health Univ of MI Health Metro Health U Of Mi Health
      • Ypsilanti, Michigan, United States, 48197
        • St. Joseph Mercy Health System
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St Marys Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota .
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Center Multiple Sclerosis Drug Shipment
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Heart and Vascular Institute
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart and Vascular Center
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital Main Center
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Belzoni Clinical Research
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
      • Jackson, Mississippi, United States, 39216
        • VAMC Research-G V Sonny Montgomery Clinic
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates of North MS
      • Yazoo City, Mississippi, United States, 39194
        • Yazoo Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Saint Louis, Missouri, United States, 63125-4181
        • St Louis V A Medical Center .
      • Saint Louis, Missouri, United States, 63128
        • Gateway Cardiovascular Rsch Ctr Inc
      • Saint Louis, Missouri, United States, 63128
        • Mercy South .
      • Saint Louis, Missouri, United States, 63136
        • St Louis Heart and Vascular .
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital .
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clinic Heart Consultants
      • Omaha, Nebraska, United States, 68105
        • VA Medical Center - NWI, Endocrine Studies (R151) Western Iowa Hlth Care Sys
      • Omaha, Nebraska, United States, 68130
        • CCT Research Research
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Las Vegas Endocrinology
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada .
    • New Hampshire
      • Manchester, New Hampshire, United States, 03062
        • Catholic Medical Center
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Monmouth Cardiology Associates
      • Haddon Heights, New Jersey, United States, 08035
        • Cooper University Health Care .
      • Linden, New Jersey, United States, 07036
        • New Jersey Heart
      • Manalapan, New Jersey, United States, 07726
        • Garden State Heart Care
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School CFTY720D2403
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • Somerset, New Jersey, United States, 08873
        • Cardio Metabolic Institute CACZ885M2301
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • Albany, New York, United States, 12206
        • Albany Medical College Div of Community Endocrinology
      • Binghamton, New York, United States, 13901
        • Meridian Clinical Research
      • Cooperstown, New York, United States, 13326
        • Bassett Medical Center
      • Endwell, New York, United States, 13760
        • Meridian Clinical Research LLC
      • Mineola, New York, United States, 11501
        • NYU Langone Hlth Card Assoc
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetes and Endocrine Associates
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Med at Mt Sinai
      • Northport, New York, United States, 11768
        • Northport VA Medical Center
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
      • Stony Brook, New York, United States, 11794-3362
        • State Uni of NY at Stony Brook
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center .
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Institute .
      • Charlotte, North Carolina, United States, 28277
        • Novant Health Heart and Vascular Institute
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research LLC
      • Salisbury, North Carolina, United States, 28144
        • Accellacare
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest U of Health Sciences-Cardiology Dept
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center StudyCoordinator
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health Research Dept.
    • Ohio
      • Akron, Ohio, United States, 44304
        • Akron Hospital Summa Health System Akron Hospital
      • Cincinnati, Ohio, United States, 45246
        • Meridian Clinical Research
      • Cincinnati, Ohio, United States, 45267
        • University Of Cincinnati .
      • Cleveland, Ohio, United States, 44106-5028
        • University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Marion, Ohio, United States, 43302
        • Rama Research, LLC
      • Springfield, Ohio, United States, 45505
        • Heart House Research Foundation
      • Toledo, Ohio, United States, 43608
        • Mercy Health St Vincent Med Ctr
      • Vandalia, Ohio, United States, 45377
        • Premier Cardiovascular Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Oklahoma Heart Institute .
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Corvallis, Oregon, United States, 97330
        • Samaritan Cardiology
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Jefferson Abington
      • Butler, Pennsylvania, United States, 16001
        • Butler Memorial Hospital
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC .
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research LLC
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians, Inc.
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Kent County Memorial Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Univ of South Carolina CTBM100C2407
      • Columbia, South Carolina, United States, 29203
        • Columbia Heart Clinic
      • Columbia, South Carolina, United States, 29209
        • Columbia VA Health Care System
      • Greenville, South Carolina, United States, 29607
        • Upstate Cardiology
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Upstate .
      • Ladson, South Carolina, United States, 29465
        • Trident Cardiology
      • Myrtle Beach, South Carolina, United States, 29588
        • Family Medicine of Sayebrook
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford University of South Dakota Medical Center Sanford Cardiovascular Institu
      • Sioux Falls, South Dakota, United States, 57105
        • North Central Heart .
    • Tennessee
      • Greenville, Tennessee, United States, 37745
        • Wellmont CVA Heart Institute
      • Jackson, Tennessee, United States, 38301
        • Apex Cardiology Research Associates of Jackson
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic PA Research
      • Knoxville, Tennessee, United States, 37912
        • Accellacare .
      • Knoxville, Tennessee, United States, 37917
        • Turkey Creek Medical Center
      • Knoxville, Tennessee, United States, 37934
        • Turkey Creek Medical Center .
      • Memphis, Tennessee, United States, 38119
        • Memphis Cardiology and Vein Ct
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center For Clinical Trials
    • Texas
      • Amarillo, Texas, United States, 79106-4165
        • PharmaTex Research LLC
      • Bedford, Texas, United States, 76021
        • North Hills Medical Research, Inc .
      • Dallas, Texas, United States, 75235
        • Southwest Family Medicine Associates
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75226
        • Soltero Cardiovascular Research Center
      • Dallas, Texas, United States, 75231
        • Texas Health Physicians Group
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System .
      • Dallas, Texas, United States, 75231
        • Research Institute of Dallas, PA
      • El Paso, Texas, United States, 79905
        • David Turbay MD PLLC
      • Fort Worth, Texas, United States, 76107
        • Texas Health Physicians Group
      • Fort Worth, Texas, United States, 76104
        • Texas Health Physicians Group
      • Houston, Texas, United States, 77034
        • Orion Medical
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital .
      • Houston, Texas, United States, 77030
        • UT Physicians Memorial Hermann
      • Houston, Texas, United States, 77084
        • BioStar Clinical Research
      • Houston, Texas, United States, 77084
        • Village Medical Village MD S Tx
      • Lampasas, Texas, United States, 76550
        • FMC Science Research
      • Livingston, Texas, United States, 77351
        • East Texas Research Associates Inc.
      • McAllen, Texas, United States, 78503
        • Discovery Clinical Trials
      • McKinney, Texas, United States, 75071
        • CardioVoyage LLC Abo Auda Associates
      • Pflugerville, Texas, United States, 78660-3015
        • Discovery Clinical Trials .
      • Plano, Texas, United States, 75075
        • Heartplace-Plano Main Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio .
      • San Antonio, Texas, United States, 78229
        • Sou Tx Cardiovascular Consu PLLC .
      • San Antonio, Texas, United States, 78240
        • Endeavor Clinical Trials .
      • San Marcos, Texas, United States, 78666
        • Javara Research
      • Sherman, Texas, United States, 75092
        • Sherman Clinical Research
      • Stephenville, Texas, United States, 76401
        • Stephenville Med and Surgical
      • Sugar Land, Texas, United States, 77478
        • Privia Medical Group Gulf Coast
      • The Woodlands, Texas, United States, 77382
        • Javara Research
    • Utah
      • Bountiful, Utah, United States, 84010
        • Progressive Clinical Research
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine and Research
      • Forest, Virginia, United States, 24551
        • Javara Research
      • Hopewell, Virginia, United States, 23860
        • Heart Care Associates, P.C.
      • Norfolk, Virginia, United States, 23510
        • York Clinical Research
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
      • Roanoke, Virginia, United States, 24014
        • Roanoke Heart Institute
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Centre
      • Seattle, Washington, United States, 98122
        • Swedish Medical Ctr Cardiovascular Re
      • Seattle, Washington, United States, 98195
        • University of Washington Clin Atherosclerosis Res Lab
      • Tacoma, Washington, United States, 98405
        • Universal Research Group LLC Suite 202
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Fasting LDL-C ≥ 70 mg/dL at randomization visit
  2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
  3. Established CV disease defined as ANY of the following three conditions

    1. Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
    2. History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
    3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.

Exclusion Criteria:

  1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit
  2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
  3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
  4. Heart failure NYHA class III or IV
  5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
  6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
  7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
  8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
  9. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subcutaneous injection
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
Experimental: Inclisiran sodium
Subcutaneous injection
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Time Frame: From randomization to total follow-up time (up to 72 months)
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
From randomization to total follow-up time (up to 72 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Occurrence of Cardiovascular (CV) Death
Time Frame: From randomization to total follow-up time (up to 72 months)
CV death is defined as death due to cardiovascular events
From randomization to total follow-up time (up to 72 months)
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
Time Frame: From randomization to total follow-up time (up to 72 months)
A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization.
From randomization to total follow-up time (up to 72 months)
Time to occurrence of all-cause death
Time Frame: From randomization to total follow-up time (up to 72 months)
All-Cause death is defined as: all deaths from randomization until up to 72 months
From randomization to total follow-up time (up to 72 months)
Time to first occurrence of Major Limb Adverse Events (MALE)
Time Frame: From randomization to total follow-up time (up to 72 months)
Major Limb Adverse Events including acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia
From randomization to total follow-up time (up to 72 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Estimated)

October 13, 2027

Study Completion (Estimated)

October 13, 2027

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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