An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

May 14, 2026 updated by: Novartis Pharmaceuticals

A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Study Type

Interventional

Enrollment (Estimated)

5700

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, C1280AEB
        • Recruiting
        • Novartis Investigative Site
      • Caba, Argentina, C1426
        • Recruiting
        • Novartis Investigative Site
      • Capital Federal, Argentina, C1023AAB
        • Recruiting
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400CDS
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        • Novartis Investigative Site
      • San Luis, Argentina, D5702JRS
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        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, 1407
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        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1119ACN
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        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
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        • Novartis Investigative Site
      • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
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        • Novartis Investigative Site
    • Buenos Aires F.D.
      • CABA, Buenos Aires F.D., Argentina, 1426
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        • Novartis Investigative Site
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
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        • Novartis Investigative Site
    • San Miguel de Tucuman
      • San Miguel de Tucumán, San Miguel de Tucuman, Argentina, 4000
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        • Novartis Investigative Site
      • San Miguel de Tucumán, San Miguel de Tucuman, Argentina, T4000ICL
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        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
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        • Novartis Investigative Site
      • Rosario, Santa Fe Province, Argentina, S200CVD
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        • Novartis Investigative Site
      • Santa Fe, Santa Fe Province, Argentina, S3000FWO
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        • Novartis Investigative Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
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        • Novartis Investigative Site
      • Liverpool, New South Wales, Australia, 2170
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    • Queensland
      • Chemside, Queensland, Australia, 4032
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      • Woolloongabba, Queensland, Australia, 4102
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    • Victoria
      • Clayton, Victoria, Australia, 3168
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        • Novartis Investigative Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
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      • Graz, Austria, 8036
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      • Innsbruck, Austria, 6020
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      • Linz, Austria, 4021
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      • Salzburg, Austria, 5020
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      • Vienna, Austria, 1090
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      • Vienna, Austria, 1210
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      • Bruges, Belgium, 8000
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      • Dendermonde, Belgium, 9200
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      • Huy, Belgium, 4500
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    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1070
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    • Limburg
      • Genk, Limburg, Belgium, 3600
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    • Oost Vlaanderen
      • Aalst, Oost Vlaanderen, Belgium, 9300
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    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
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      • Rio de Janeiro, Brazil, 20241-180
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    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
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    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-130
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    • Goiás
      • Goiânia, Goiás, Brazil, 74605-020
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    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-270
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      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
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      • Juiz de Fora, Minas Gerais, Brazil, 36033-318
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      • Uberlândia, Minas Gerais, Brazil, 38400 500
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    • Paraná
      • Curitiba, Paraná, Brazil, 80730-150
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    • Rio Grande do Sul
      • Canoas, Rio Grande do Sul, Brazil, 92425 900
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      • Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
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      • Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
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    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89020-430
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    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-530
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    • São Paulo
      • Campinas, São Paulo, Brazil, 13060 080
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      • Campinas, São Paulo, Brazil, 13092133
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      • Ribeirão Preto, São Paulo, Brazil, 14026-020
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      • Santo André, São Paulo, Brazil, 09090-790
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      • Santo André, São Paulo, Brazil, 09060-870
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      • Sao Jose Rio Preto, São Paulo, Brazil, 15090 000
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      • Sao Jose Rio Preto, São Paulo, Brazil, 15015-750
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      • São Paulo, São Paulo, Brazil, 01323 000
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      • São Paulo, São Paulo, Brazil, 04005-003
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      • São Paulo, São Paulo, Brazil, 04266 010
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      • São Paulo, São Paulo, Brazil, 05403-900
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      • Burgas, Bulgaria, 8001
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      • Pernik, Bulgaria, 2300
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      • Pleven, Bulgaria, 5800
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      • Plovdiv, Bulgaria, 4000
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      • Rousse, Bulgaria, 7002
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      • Sofia, Bulgaria, 1233
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    • Ontario
      • Oakville, Ontario, Canada, L6K 3W7
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      • Toronto, Ontario, Canada, M9V 4B4
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    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
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      • Montreal, Quebec, Canada, H1T 1C8
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      • Beijing, China, 100730
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      • Beijing, China, 100050
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      • Beijing, China, 100191
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      • Shanghai, China, 200025
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      • Shanghai, China, 200040
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      • Shanghai, China, 200120
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      • Shanghai, China, 200065
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      • Tianjin, China, 300052
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      • Tianjin, China, 030045
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      • Tianjin, China, 300121
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      • Xiamen, China, 361004
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    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100013
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    • Gansu
      • Lanzhou, Gansu, China, 730030
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    • Guangdong
      • Foshan, Guangdong, China, 528000
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        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510080
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        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510030
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        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Novartis Investigative Site
      • Changsha, Hunan, China, 410003
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        • Novartis Investigative Site
      • Changsha, Hunan, China, 410008
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        • Novartis Investigative Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
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        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
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        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210029
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      • Nanjing, Jiangsu, China, 211166
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      • Suzhou, Jiangsu, China, 215004
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      • Xuzhou, Jiangsu, China, 221003
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    • Jilin
      • Changchun, Jilin, China, 130021
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    • Liaoning
      • Dalian, Liaoning, China, 116011
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        • Novartis Investigative Site
      • Shenyang, Liaoning, China, 110016
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      • Shenyang, Liaoning, China, 110004
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    • Shandong
      • Jinan, Shandong, China, 250013
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    • Shanxi
      • Xian, Shanxi, China, 710061
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    • Sichuan
      • Chengdu, Sichuan, China, 610041
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        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
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    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
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      • Hangzhou, Zhejiang, China, 310016
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      • Wenzhou, Zhejiang, China, 325000
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      • Bogotá, Colombia, 111211
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        • Novartis Investigative Site
      • Medellín, Colombia, 050037
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        • Novartis Investigative Site
      • San Gil, Colombia, 684031
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    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
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    • Colombia
      • Barranquilla, Colombia, Colombia, 080020
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        • Novartis Investigative Site
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 681017
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        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
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        • Novartis Investigative Site
      • Cali, Valle del Cauca Department, Colombia, 760001
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        • Novartis Investigative Site
      • Brandýs nad Labem, Czechia, 250 01
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        • Novartis Investigative Site
      • Brno, Czechia, 625 00
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      • Brno, Czechia, 602 00
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      • Broumov, Czechia, 550 01
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      • CZE, Czechia, 110 00
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      • Hlučín, Czechia, 748 01
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      • Hodonín, Czechia, 695 01
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      • Jihlava, Czechia, 586 01
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      • Kolín, Czechia, 280 20
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      • Liberec, Czechia, 460 01
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      • Liberec, Czechia, 460 05
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      • Mariánské Lázně, Czechia, 353 01
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      • Most, Czechia, 434 01
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      • Mělník, Czechia, 276 01
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      • Olomouc, Czechia, 779 00
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      • Ostrava, Czechia, 700 30
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      • Pardubice, Czechia, 532 03
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      • Polička, Czechia, 57201
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      • Prague, Czechia, 128 08
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      • Prague, Czechia, 110 00
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      • Přerov, Czechia, 751 52
        • Withdrawn
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      • Slaný, Czechia, 274 01
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      • Trutnov, Czechia, 460 63
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      • Třebíč, Czechia, 674 01
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      • Uherské Hradiště, Czechia, 686 01
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      • Valašské Meziříčí, Czechia, 75742
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      • Zlín, Czechia, 760 01
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      • Český Krumlov, Czechia, 381 01
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    • Chlumec Nad Cidlinou
      • Chlumec nad Cidlinou, Chlumec Nad Cidlinou, Czechia, 503 51
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    • Czech Republic
      • Kroměříž, Czech Republic, Czechia, 767 55
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      • Louny, Czech Republic, Czechia, 440 01
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      • Ostrava, Czech Republic, Czechia, 725 27
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      • Ústí nad Labem, Czech Republic, Czechia, 400 01
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    • Zabreh
      • Ostrava, Zabreh, Czechia, 700 30
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        • Novartis Investigative Site
      • Aarhus N, Denmark, 8200
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      • Copenhagen, Denmark, DK-2100
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      • Esbjerg, Denmark, 6700
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      • Gistrup, Denmark, 9260
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      • Herlev, Denmark, DK-2730
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      • Roskilde, Denmark, 4000
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      • Viborg, Denmark, 8800
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        • Novartis Investigative Site
      • Bron, France, 69677
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      • Chambray-lès-Tours, France, 37170
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      • Grenoble, France, 38043
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      • Le Coudray, France, 28630
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      • Nantes, France, 44093
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      • Paris, France, 75018
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      • Toulouse, France, 31054
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      • Valenciennes, France, 59300
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      • Aachen, Germany, 52074
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      • Bad Homburg, Germany, 61348
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      • Bad Krozingen, Germany, 79189
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      • Bad Oeynhausen, Germany, 32545
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      • Bamberg, Germany, 96049
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      • Berlin, Germany, 13353
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      • Berlin, Germany, 10787
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      • Berlin, Germany, 10367
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      • Berlin, Germany, 10789
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      • Berlin, Germany, 13347
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      • Berlin, Germany, 10559
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      • Bielefeld, Germany, 33604
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      • Dessau, Germany, 06846
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      • Dortmund, Germany, 44137
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      • Dresden, Germany, 01307
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      • Dresden, Germany, 01069
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      • Dresden, Germany, 01277
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      • Essen, Germany, 45277
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      • Essen, Germany, 45355
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      • Essen, Germany, 45359
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      • Gelnhausen, Germany, 63571
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      • Hamburg, Germany, 22041
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      • Hamburg, Germany, 22607
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      • Kassel, Germany, 34121
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      • Lüneburg, Germany, 21339
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      • Magdeburg, Germany, 39120
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      • Mannheim, Germany, 68165
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      • Meissen, Germany, 01662
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      • München, Germany, 80636
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      • Münster, Germany, 48149
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      • Potsdam, Germany, 14471
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      • Rüdersdorf, Germany, 15562
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      • Ulm, Germany, 89077
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      • Warendorf, Germany, 48231
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    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68305
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    • Bavaria
      • Muehldorf Am Inn, Bavaria, Germany, 84453
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      • Munich, Bavaria, Germany, 81377
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      • Weiden in Der Oberpfalz, Bavaria, Germany, 92637
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    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
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      • Frankfurt am Main, Hesse, Germany, 60594
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    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30159
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    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
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      • Cologne, North Rhine-Westphalia, Germany, 50733
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      • Essen, North Rhine-Westphalia, Germany, 45355
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      • Löhne, North Rhine-Westphalia, Germany, 32584
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    • Saarland
      • Saint Ingbert, Saarland, Germany, 66386
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    • Saxony
      • Chemnitz, Saxony, Germany, 09113
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      • Dresden, Saxony, Germany, 01307
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      • Dresden, Saxony, Germany, 01099
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      • Leipzig, Saxony, Germany, 04103
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    • Saxony-Anhalt
      • Wittenberg, Saxony-Anhalt, Germany, 06886
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    • Thuringia
      • Jena, Thuringia, Germany, 07740
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        • Novartis Investigative Site
      • Athens, Greece, 115 27
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      • Athens, Greece, 115 21
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      • Athens, Greece, 142 33
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      • Ioannina, Greece, 455 00
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      • Larissa, Greece, 411 10
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      • Thessaloniki, Greece, 54636
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      • Hong Kong, Hong Kong, 999077
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    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
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      • Baja, Hungary, 6500
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      • Budapest, Hungary, H-1083
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      • Budapest, Hungary, H-1145
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      • Budapest, Hungary, 1211
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      • Szeged, Hungary, 6725
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    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
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      • New Delhi, India, 110025
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    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
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    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
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        • Novartis Investigative Site
      • Ahmedabad, Gujarat, India, 380060
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      • Vadodara, Gujarat, India, 390022
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        • Novartis Investigative Site
    • Karnataka
      • Belagavi, Karnataka, India, 590010
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      • Mangalore, Karnataka, India, 575018
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      • Manipal, Karnataka, India, 576104
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      • Mysore, Karnataka, India, 570015
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      • Kochi, Kerala, India, 682041
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      • Kochi, Kerala, India, 682018
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      • Kochi, Kerala, India, 682027
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      • Nagpur, Maharashtra, India, 440012
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      • Nagpur, Maharashtra, India, 440008
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      • Nagpur, Maharashtra, India, 440025
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      • Pune, Maharashtra, India, 411004
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      • Pune, Maharashtra, India, 411045
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      • Pune, Maharashtra, India, 411028
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      • New Delhi, National Capital Territory of Delhi, India, 110060
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      • New Delhi, National Capital Territory of Delhi, India, 110075
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      • Hyderabad, Telangana, India, 500082
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      • Beersheba, Israel, 8457108
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      • Naples, Italy, 80131
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      • Pozzilli, IS, Italy, 86077
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      • Amersfoort, Netherlands, 3813 TZ
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      • Hardenberg, Netherlands, 7770 SE
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      • Utrecht, Netherlands, 3584 CX
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      • Venlo, Netherlands, 5912 BL
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      • Arnhem, Gelderland, Netherlands, 6815 AD
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      • Tiel, Gelderland, Netherlands, 4002 WP
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      • Amsterdam, North Holland, Netherlands, 1090 HM
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      • Heemstede, North Holland, Netherlands, 2035 RC
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      • Sneek, Provincie Friesland, Netherlands, 8601 ZK
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      • Leiden, South Holland, Netherlands, 2333 ZA
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      • Lodz, Poland, 91 347
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      • Coimbra, Portugal, 3004-561
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      • Ponce, Puerto Rico, 00717-1322
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        • Research and Cardiovascular Corp
        • Contact:
        • Principal Investigator:
          • Jose B Vazquez-Tanus
      • Bucharest, Romania, 050098
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      • Bucharest, Romania, 010192
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      • Craiova, Dolj, Romania, 200513
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      • Baia Mare, Maramureş, Romania, 430222
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      • Chelyabinsk, Russia, 454047
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      • Izhevsk, Russia, 426061
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      • Kemerovo, Russia, 650002
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      • Kirov, Russia, 610035
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      • Krasnodar, Russia, 350086
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      • Moscow, Russia, 117198
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      • Moscow, Russia, 101990
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      • Moscow, Russia, 121552
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      • Moscow, Russia, 127473
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      • Moscow, Russia, 141060
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      • Novosibirsk, Russia, 630090
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      • Perm, Russia, 614097
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      • Rostov-on-Don, Russia, 344022
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      • Ryazan, Russia, 390039
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      • Saint Petersburg, Russia, 197341
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      • Saint Petersburg, Russia, 191015
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      • Saint Petersburg, Russia, 194354
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      • Saint Petersburg, Russia, 195197
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      • Saint Petersburg, Russia, 196143
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      • Saint Petersburg, Russia, 199178
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      • Samara, Russia, 443070
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      • Saratov, Russia, 410028
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      • Saratov, Russia, 410012
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      • Sochy, Russia, 354002
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      • Tomsk, Russia, 634009
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      • Ulyanovsk, Russia, 432063
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      • Vsevolozhsk, Russia, 188643
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      • Yaroslavl, Russia, 150062
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      • Yekaterinburg, Russia, 620028
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      • Yekaterinburg, Russia, 620137
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      • Yekaterinburg, Russia, 620144
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    • Russia
      • Saint Petersburg, Russia, Russia, 198328
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        • Novartis Investigative Site
      • Bardejov, Slovakia, 085 01
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      • Bratislava, Slovakia, 833 48
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      • Bratislava, Slovakia, 833 05
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      • Bratislava, Slovakia, 821 07
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      • Bratislava, Slovakia, 851 07
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      • Handlová, Slovakia, 972 51
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      • Komárno, Slovakia, 945 01
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      • Komárno, Slovakia, 945 05
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      • Košice, Slovakia, 040 01
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      • Lučenec, Slovakia, 984 01
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      • Nitra, Slovakia, 949 01
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      • Nitra, Slovakia, 950 01
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      • Nitra, Slovakia, 949 11
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      • Nové Zámky, Slovakia, 940 01
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      • Piešťany, Slovakia, 921 01
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      • Považská Bystrica, Slovakia, 017 01
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      • Prešov, Slovakia, 080 01
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      • Rimavská Sobota, Slovakia, 979 01
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      • Svidník, Slovakia, 089 01
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    • Slovakia
      • Trnava, Slovakia, Slovakia, 917 02
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      • Busan, South Korea, 49201
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      • Gwangju, South Korea, 61469
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      • Seoul, South Korea, 06591
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      • Seoul, South Korea, 03181
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    • Dalseo gu
      • Daegu, Dalseo gu, South Korea, 42602
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    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
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      • Bundang Gu, Gyeonggi-do, South Korea, 13620
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      • Suwon, Gyeonggi-do, South Korea, 16499
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    • Korea
      • Incheon, Korea, South Korea, 405 760
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      • Seoul, Korea, South Korea, 02841
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    • Seoul
      • Seoul, Seoul, South Korea, 03080
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        • Novartis Investigative Site
      • A Coruña, Spain, 15001
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      • Barcelona, Spain, 08025
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      • Barcelona, Spain, 08036
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      • Córdoba, Spain, 14004
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      • Huelva, Spain, 21080
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      • Madrid, Spain, 28041
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      • Madrid, Spain, 28040
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      • Málaga, Spain, 29010
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      • Seville, Spain, 41013
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      • Seville, Spain, 41009
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      • Zaragoza, Spain, 50009
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    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
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      • Seville, Andalusia, Spain, 41014
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      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
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      • Basel, Switzerland, 4031
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      • Geneva, Switzerland, 1211
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      • Lausanne, Switzerland, 1010
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      • Liestal, Switzerland, 4410
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      • Zurich, Switzerland, 8091
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      • Hsinchu, Taiwan, 30069
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      • Kaohsiung City, Taiwan, 83301
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      • Kaohsiung City, Taiwan, 80756
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      • Keelung, Taiwan, 20401
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      • Tainan, Taiwan, 71004
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      • Taipei, Taiwan, 11217
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      • Taoyuan, Taiwan, 33305
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      • Yilan, Taiwan, 26058
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    • Taiwan ROC
      • Taichung, Taiwan ROC, Taiwan, 40201
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      • Izmir, Turkey (Türkiye), 35100
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      • Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
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      • Istanbul, Fatih, Turkey (Türkiye), 34098
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      • Eskişehir, Odunpazari, Turkey (Türkiye), 26040
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      • Samsun, Samsun, Turkey (Türkiye), 55080
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      • Bristol, United Kingdom, BS2 8HW
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      • Chesterfield, United Kingdom, S40 4AA
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      • Edinburgh, United Kingdom, EH16 4SA
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      • Glasgow, United Kingdom, G20 7BE
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      • London, United Kingdom, W12 0HS
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      • Londonderry, United Kingdom, BT47 6SB
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      • Middlesbrough, United Kingdom, TS4 3BW
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      • Newport, United Kingdom, NP20 2UB
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      • Norwich, United Kingdom, NR4 7UY
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      • Sheffield, United Kingdom, S5 7AU
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      • Tyne and Wear, United Kingdom, NE29 8NH
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      • Wiltshire, United Kingdom, SN15 2SB
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      • Wrexham, United Kingdom, LL13 7TD
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    • GBR
      • London, GBR, United Kingdom, EC1M 6BQ
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    • Greater London
      • London, Greater London, United Kingdom, EN3 4GS
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      • Rochdale, North Manchester, United Kingdom, OL11 4AU
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      • Portadown, Nothern Ireland, United Kingdom, BT63 5QQ
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      • Chertsey, Surrey, United Kingdom, KT16 0PZ
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      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
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      • Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
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      • Cardiff, Wales, United Kingdom, CF5 4AD
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      • Chichester, West Sussex, United Kingdom, PO19 6SE
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    • Alabama
      • Andalusia, Alabama, United States, 36420
        • Recruiting
        • SEC Clinical Research LLC
        • Principal Investigator:
          • Andreas Muench
        • Contact:
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center Research LLC
        • Principal Investigator:
          • Vernon R Hunter
        • Contact:
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Mobile Heart Specialists
        • Principal Investigator:
          • Christopher S Brown
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Mercy Gilbert Medical Center
        • Principal Investigator:
          • Nabil Dib
        • Contact:
      • Sun City West, Arizona, United States, 85375
        • Recruiting
        • Clinical Research Inst of Arizona
        • Principal Investigator:
          • Jalal Abbas
        • Contact:
      • Tucson, Arizona, United States, 85745
        • Recruiting
        • Eclipse Clinical Research
        • Principal Investigator:
          • Eve Shapiro
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Cardiovascular Res Found
        • Principal Investigator:
          • Ronald P Karlsberg
        • Contact:
      • Covina, California, United States, 91723
      • Los Angeles, California, United States, 90033
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF
        • Principal Investigator:
          • Eveline O Stock
        • Contact:
      • Santa Ana, California, United States, 92704
        • Recruiting
        • Helping Hands Medical Associates INC
        • Principal Investigator:
          • Alan Charles Schwartz
        • Contact:
      • Stockton, California, United States, 95204
        • Recruiting
        • Manshadi Heart Institute
        • Contact:
        • Principal Investigator:
          • Ramin Manshadi
      • West Hills, California, United States, 91307
        • Recruiting
        • Interv Cardiology Med Grp
        • Principal Investigator:
          • Farhad Rafii
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • ANTONIO FERNANDEZ
        • Contact:
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Chase Medical Research LLC
        • Contact:
        • Principal Investigator:
          • Ashish Adlakha
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials LLC
        • Principal Investigator:
          • Rasha Youssef
        • Contact:
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Bay Area Cardiology Assoc
        • Principal Investigator:
          • Ranchhod Khant
        • Contact:
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Principal Investigator:
          • Michael J Koren
        • Contact:
      • Naples, Florida, United States, 34102
        • Recruiting
        • Advanced Research for Health Improvement LLC
        • Principal Investigator:
          • Julian Javier
        • Contact:
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Peace River Cardiovascular Center
        • Contact:
        • Principal Investigator:
          • David Allan Hotchkiss
      • Port Orange, Florida, United States, 32127
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • East Coast Inst for Research LLC
        • Principal Investigator:
          • Ferris George
        • Contact:
      • Wellington, Florida, United States, 33449
        • Recruiting
        • Cardiology Partners Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Neerav Suresh Shah
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Arshed Quyyumi
        • Contact:
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Cardiovascular Consultants of S GA
        • Contact:
        • Principal Investigator:
          • Christopher Daniels
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Annabelle Volgman
    • Indiana
      • Indianapolis, Indiana, United States, 46202 4800
        • Recruiting
        • Krannert Institute of Cardiology
        • Principal Investigator:
          • Julie Clary
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Uni Of Iowa Hospitals And Clinics
        • Principal Investigator:
          • Marcelo Correia
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Hospital
        • Contact:
        • Principal Investigator:
          • Patrick M Moriarty
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O Neil Clinical Res Center
        • Principal Investigator:
          • Michael Cox
        • Contact:
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Cardiovascular Associates Research
        • Principal Investigator:
          • Dale Presser
        • Contact:
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Louisiana Heart Center Research
        • Principal Investigator:
          • Bruce J Iteld
        • Contact:
      • Lafayette, Louisiana, United States, 70501
        • Recruiting
        • Horizon Research Grp
        • Contact:
        • Principal Investigator:
          • Randall Miller
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Omega Clinical Research
        • Principal Investigator:
          • Tuan-Huy Tran
        • Contact:
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • Keith C Ferdinand.
      • Opelousas, Louisiana, United States, 70570
        • Recruiting
        • CV Ins of the South
        • Principal Investigator:
          • Siby George Ayalloore
        • Contact:
      • Shreveport, Louisiana, United States, 71105
      • Zachary, Louisiana, United States, 70791
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Sinai Ct for Throm Res and Drug Dev
        • Principal Investigator:
          • Paul Gurbel
        • Contact:
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Daniel Kim
        • Contact:
      • Ft. Washington, Maryland, United States, 20744
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Adventist HealthCare Shady Grove Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Chen
    • Massachusetts
      • Boston, Massachusetts, United States, 02114 2696
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Khaled Abdul-Nour
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University
        • Principal Investigator:
          • Brian J O Neil
        • Contact:
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA Medical Research Center
        • Principal Investigator:
          • Ahmed A Arif
        • Contact:
      • Kalamazoo, Michigan, United States, 49008
        • Recruiting
        • Western Michigan University
        • Principal Investigator:
          • Vishal Gupta
        • Contact:
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • McLaren Ctr Research Innovation
        • Contact:
        • Principal Investigator:
          • Joel Engel
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Metro Health Univ of MI Health
        • Contact:
        • Principal Investigator:
          • Rony Gorges
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint Johns Hospital
        • Contact:
        • Principal Investigator:
          • Les B Forgosh
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Contact:
        • Principal Investigator:
          • Thomas Knickelbine
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Daniel Duprez
        • Contact:
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Stern Cardiovascular Foundation Inc
        • Principal Investigator:
          • Dharmesh Patel
        • Contact:
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • Recruiting
        • StudyMetrix Research
        • Principal Investigator:
          • Timothy Smith
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Quality Clinical Research
        • Contact:
        • Principal Investigator:
          • John Hallgren
    • New Jersey
      • Summit, New Jersey, United States, 07901
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Bani Azari
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical Center
        • Principal Investigator:
          • Samuel Kim
        • Contact:
      • New York, New York, United States, 43210
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Eugenia Gianos
        • Contact:
      • Riverhead, New York, United States, 11901
        • Recruiting
        • Northwell Health Physician Peconic
        • Principal Investigator:
          • Sean Donahoe
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Heart Vas Inst
        • Principal Investigator:
          • Anish Vani
        • Contact:
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Medication Management LLC
        • Principal Investigator:
          • James Franklin
        • Contact:
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Accellacare US Inc
        • Principal Investigator:
          • John Rubino
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Baptist Medical Center
        • Principal Investigator:
          • Michael Shapiro
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Contact:
        • Principal Investigator:
          • Ramana Podugu
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Ctr At The Christ Hosp
        • Contact:
        • Principal Investigator:
          • Dean J Kereiakes
      • Marion, Ohio, United States, 43302
        • Recruiting
        • Rama Research LLC
        • Principal Investigator:
          • Bhola Rama
        • Contact:
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
      • Yardley, Pennsylvania, United States, 19067
        • Recruiting
        • Cardiology Consultants of Philadelphia
        • Principal Investigator:
          • Paul Grena
        • Contact:
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health Clinical Research
        • Contact:
        • Principal Investigator:
          • Stephen Wasemiller
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The Stern Cardiovascular Foundation
        • Principal Investigator:
          • Frank Augustus McGrew
        • Contact:
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Apex Cardiology Research Associates of Jackson
        • Principal Investigator:
          • Mohsin Alhaddad
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Univ Medi Cen
        • Contact:
        • Principal Investigator:
          • MacRae Linton
      • Powell, Tennessee, United States, 37849
        • Recruiting
        • Cardiovascular Res of Knoxville LLC
        • Principal Investigator:
          • Charles B Treasure
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • North Texas Endocrine Center
        • Principal Investigator:
          • Peter Bressler
        • Contact:
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Soltero Cardiovascular Research Center
        • Principal Investigator:
          • Cara East
        • Contact:
      • Dallas, Texas, United States, 75235
        • Recruiting
        • SW Family Medicine Associates
        • Principal Investigator:
          • Chrisette Dharma
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Christie M Ballantyne
      • Marshall, Texas, United States, 75670
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Northwest Houston Clinical Research PLLC
        • Principal Investigator:
          • Shamaila Aslam
        • Contact:
    • Utah
      • Bountiful, Utah, United States, 84010
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Jeffrey Anderson
        • Contact:
      • Salt Lake City, Utah, United States, 84132-0001
        • Recruiting
        • The University of Utah
        • Contact:
        • Principal Investigator:
          • Aaron Shoskes
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
        • Principal Investigator:
          • Jared Spitz
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Virginia Heart
        • Principal Investigator:
          • Tariq Haddad
        • Contact:
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Carient Heart and Vascular
        • Principal Investigator:
          • Vikram Prasanna
        • Contact:
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates
        • Principal Investigator:
          • Richard A Jackson
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center
        • Principal Investigator:
          • Francis Kim
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-Cardiovascular Research
        • Contact:
        • Principal Investigator:
          • John Petersen II.
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Hospital
        • Principal Investigator:
          • Sudarshan Balla
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
  • Participants who have completed the parent study EOS visit while still on assigned investigational product.

Exclusion Criteria:

  • Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
  • Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
  • Participants are receiving another investigational drug or device before the open-label treatment period.
  • Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelacarsen (TQJ230)
open-label pelacarsen 80mg
pelacarsen 80mg s.c. monthly
Other Names:
  • TQJ230

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse events
Time Frame: Up to 36 months
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Time Frame: Up to 36 months
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented
Up to 36 months
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Time Frame: Up to 36 months
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented
Up to 36 months
Cumulative number of 4P-MACE over time from OLE study baseline
Time Frame: Up to 36 months
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented
Up to 36 months
Cumulative number of 4P-MACE over time from parent study baseline
Time Frame: Up to 36 months
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented
Up to 36 months
Observed value of Lipoprotein(a) (Lp(a))
Time Frame: Baseline, Month 3, Month 12, Month 24, Month 36
Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported.
Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the OLE study
Time Frame: Baseline, Month 3, Month 12, Month 24, Month 36
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study.
Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the parent study
Time Frame: Baseline, Month 3, Month 12, Month 24, Month 36
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study.
Baseline, Month 3, Month 12, Month 24, Month 36

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)

May 11, 2026

Primary Completion (Estimated)

January 9, 2030

Study Completion (Estimated)

January 9, 2030

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

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.

Clinical Trials on Cardiovascular Disease and Lipoprotein(a)

Clinical Trials on Pelacarsen (TQJ230)

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