A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: Apixaban; Drug: Acetylsalicylic acid; Drug: vitamin K antagonist; Other: Acetylsalicylic acid placebo

Detailed Description

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

• Study Type: Interventional
• Enrollment (Actual): 4614
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1118
    • Local Institution
  • Buenos Aires, Argentina, 1430
    • Local Institution
  • Buenos Aires, Argentina, C1093AAS
    • Local Institution
  • Buenos Aires, Argentina, C1155ADP
    • Local Institution
  • Buenos Aires, Argentina, C1179AAB
    • Local Institution
  • Buenos Aires, Argentina, C1221ADC
    • Local Institution
  • Buenos Aires, Argentina, C1425AGC
    • Local Institution
  • Buenos Aires, Argentina, C1428CRC
    • Local Institution
  • Buenos Aires, Argentina, C1428DCO
    • Local Institution
  • Cordoba, Argentina, 5000
    • Local Institution
  • Cordoba, Argentina, X5002AOQ
    • Local Institution
  • Cordoba, Argentina, X5016KEH
    • Local Institution
  • Cordoba, Argentina, 5016
    • Local Institution
  • Cordoba, Argentina, X5000AAX
    • Local Institution
  • Cordoba, Argentina, X5000EPU
    • Local Institution
  • Cordoba, Argentina, X5004CDT
    • Local Institution
  • Cordoba, Argentina, X5006CBI
    • Local Institution
  • Cordoba, Argentina, X5008KKF
    • Local Institution
  • Corrientes, Argentina, W3400AMZ
    • Local Institution
  • Santa Fe, Argentina, 3000
    • Local Institution
  • Santa Fe, Argentina, S3000AOL
    • Local Institution
  • Santa Fe, Argentina, S3000EOZ
    • Local Institution
  • Santiago Del Estero, Argentina
    • Local Institution
  • BUA
    • Buenos Aires, BUA, Argentina, 1180
      • Local Institution
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, B8000FTD
      • Local Institution
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1406
      • Local Institution
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1431
      • Local Institution
    • Coronel Suarez, Buenos Aires, Argentina, B7540DOL
      • Local Institution
    • Lanus Oeste, Buenos Aires, Argentina, 4843
      • Local Institution
    • Mar Del Plata, Buenos Aires, Argentina, B7602CBM
      • Local Institution
    • Mar del Plata, Buenos Aires, Argentina, 7500
      • Local Institution
    • Quilmes, Buenos Aires, Argentina, 1878
      • Local Institution
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Local Institution
    • Ramos Mejia, Buenos Aires, Argentina, B1704ESN
      • Local Institution
    • Ramos Mejia, Buenos Aires, Argentina, B1704ETD
      • Local Institution
    • Vicente Lopez, Buenos Aires, Argentina, B1602ABQ
      • Local Institution
  • Chaco
    • Resistencia, Chaco, Argentina, H3500CDL
      • Local Institution
  • Cordoba
    • Ciudad De Cordoba, Cordoba, Argentina, X5000JHGQ
      • Local Institution
    • Villa Allende, Cordoba, Argentina, 5105
      • Local Institution
    • Villa Maria, Cordoba, Argentina, X5901ACH
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  • Santa FE
    • Rosario, Santa FE, Argentina, S2000DSV
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    • Rosario, Santa FE, Argentina, 2000
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    • Rosario, Santa FE, Argentina, S2000PBJ
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• Australia
  • Bedford Park, Australia, 5024
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  • New South Wales
    • Concord, New South Wales, Australia, 2139
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    • Port Macquarie, New South Wales, Australia, 2444
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  • Queensland
    • Milton, Queensland, Australia, 4064
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  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
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• Austria
  • Graz, Austria, 8036
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  • Graz, Austria, 8020
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  • Linz, Austria, 4010
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  • Linz, Austria, 4021
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  • Vienna, Austria, A-1090
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  • Wien, Austria, 1160
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  • Wien, Austria, 1100
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• Belgium
  • Aalst, Belgium, 9300
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  • Antwerpen, Belgium, 2020
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  • Bonheiden, Belgium, 2820
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  • Brasschaat, Belgium, 2930
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  • Bruxelles, Belgium, 1000
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  • Gent, Belgium, 9000
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  • Ieper, Belgium, 8900
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  • Leuven, Belgium, 3000
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  • Wilrijk, Belgium, 2610
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  • Yvoir, Belgium, 5530
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• Brazil
  • Rio de Janeiro, Brazil, 22271-100
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  • Sao Paulo, Brazil, 05403-000
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  • Sao Paulo, Brazil, 01418-100
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  • Bahia
    • Salvador, Bahia, Brazil, 40050-410
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    • Salvador, Bahia, Brazil, 41253-190
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    • Salvador, Bahia, Brazil, 41810-011
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    • Salvador, Bahia, Brazil, 41950-275
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  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70390-700
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  • Espirito Santo
    • Colatina, Espirito Santo, Brazil, 29702-020
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  • Goias
    • Aparecida de Goiania, Goias, Brazil, 74915-520
      • Local Institution
    • Goiania, Goias, Brazil, 74210-050
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  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-320
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    • Belo Horizonte, Minas Gerais, Brazil, 30110-921
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    • Uberaba, Minas Gerais, Brazil, 38025-260
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    • Uberlandia, Minas Gerais, Brazil, 38400-902
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  • Para
    • Belem, Para, Brazil, 66087-660
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  • Parana
    • Campina Grande Do Sul, Parana, Brazil, 83430-000
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    • Londrina, Parana, Brazil, 86010-450
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  • Pernambuco
    • Recife, Pernambuco, Brazil, 50100-060
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    • Recife, Pernambuco, Brazil, 52051-380
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  • RIO Grande DO SUL
    • Canoas, RIO Grande DO SUL, Brazil, 92425-900
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    • Passo Fundo, RIO Grande DO SUL, Brazil, 99010-080
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 90020-090
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 90620-001
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    • Porto Alegre, RIO Grande DO SUL, Brazil, 90840-440
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  • SAO Paulo
    • Campinas, SAO Paulo, Brazil, 13060080
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    • Limeira, SAO Paulo, Brazil, 13480-470
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    • Marilia, SAO Paulo, Brazil, 17515-000
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    • S?o Paulo, SAO Paulo, Brazil, 01327-010
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    • S?o Paulo, SAO Paulo, Brazil, 04004-030
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    • S?o Paulo, SAO Paulo, Brazil, 08270-070
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    • Santo Andre, SAO Paulo, Brazil, 09030-010
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    • Sao Jose Do Rio Preto, SAO Paulo, Brazil, 15015-750
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    • Votuporanga, SAO Paulo, Brazil, 15500-003
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  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-906
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    • Itajai, Santa Catarina, Brazil, 88301-303
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• Bulgaria
  • Burgas, Bulgaria, 8000
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  • Dimitrovgrad, Bulgaria, 6400
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  • Haskovo, Bulgaria, 6300
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  • Montana, Bulgaria, 3400
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  • Pazardzhik, Bulgaria, 4400
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  • Pleven, Bulgaria, 5800
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  • Plovdiv, Bulgaria, 4002
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  • Sandanski, Bulgaria, 2800
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  • Smolyan, Bulgaria, 4700
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  • Sofia, Bulgaria, 1202
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  • Sofia, Bulgaria, 1407
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  • Sofia, Bulgaria, 1431
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  • Sofia, Bulgaria, 1505
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  • Sofia, Bulgaria, 1527
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  • Sofia, Bulgaria, 1606
    • Local Institution
  • Veliko Tarnova, Bulgaria, 5000
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  • Vidin, Bulgaria, 3700
    • Local Institution
• Canada
  • Montreal, Canada, H2X 3E4
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  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Local Institution
    • Edmonton, Alberta, Canada, T5H 3V9
      • Local Institution
    • Edmonton, Alberta, Canada, T6K 4C1
      • Local Institution
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1V6
      • Local Institution
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Local Institution
    • Victoria, British Columbia, Canada, V8R 4R2
      • Local Institution
  • Manitoba
    • Winnepeg, Manitoba, Canada, R2H 2A6
      • Local Institution
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H1V7
      • Local Institution
  • Ontario
    • Cambridge, Ontario, Canada, N1R 7R1
      • Local Institution
    • London, Ontario, Canada, N6A 5A5
      • Local Institution
    • Oshawa, Ontario, Canada, L1J 2J9
      • Local Institution
    • Scarborough, Ontario, Canada, M1E 5E9
      • Local Institution
    • Scarborough, Ontario, Canada, M1P 2T7
      • Local Institution
    • Sudbury, Ontario, Canada, P3E 3B8
      • Local Institution
    • Sudbury, Ontario, Canada, P3E 5M4
      • Local Institution
    • Waterloo, Ontario, Canada, N2T 0C1
      • Local Institution
  • Quebec
    • Green Field Park, Quebec, Canada, J4V 2H1
      • Local Institution
    • Laval, Quebec, Canada, H7M 3L9
      • Local Institution
    • Longueuil, Quebec, Canada, J4M 2X1
      • Local Institution
    • Montreal, Quebec, Canada, H3G 1A4
      • Local Institution
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution
    • St-Georges, Beauce, Quebec, Canada, G5Y 4T8
      • Local Institution
    • St-Jean-sur-Richelieu, Quebec, Canada, J3A 1C3
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    • St. Jerome, Quebec, Canada, J7Z 5T3
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  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
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• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7500588
      • Local Institution
• Colombia
  • Barranquilla, Colombia, 84-176
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  • Barranquilla, Colombia
    • Local Institution
  • Bogota, Colombia
    • Local Institution
  • Cali, Colombia, 760032
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  • Espinal, Colombia
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  • Medellin, Colombia
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• Croatia
  • Cakovec, Croatia, 40000
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  • Dubrovnik, Croatia, 20000
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  • Karlovac, Croatia, 47000
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  • Krapinske toplice, Croatia, 49217
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  • Opatija, Croatia, 51410
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  • Osijek, Croatia, 31000
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  • Rijeka, Croatia, 51000
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  • Sibenik, Croatia, 22000
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  • Slavonski Brod, Croatia, 35000
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  • Virovitica, Croatia, 33000
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  • Zabok, Croatia, 49210
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  • Zadar, Croatia, 23000
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  • Zagreb, Croatia, 10000
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• Czechia
  • Prague 8, Czechia, 180 85
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  • Praha 2, Czechia, 128 08
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  • Praha 5, Czechia, 150 06
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  • Tabor, Czechia, 390 03
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  • Usti Nad Orlici, Czechia, 562 18
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  • Zlin, Czechia, 762 75
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• Denmark
  • Aabenraa, Denmark, 6200
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  • Aarhus, Denmark, 8000
    • Local Institution
  • Copenhagen, Denmark, DK-2300
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  • Frederiksburg, Denmark, 2000
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  • Hellerup, Denmark, DK-2900
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  • Hillerod, Denmark, DK-3400
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  • Holb?k, Denmark, DK-4300
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  • Hvidovre, Denmark, DK-2650
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  • Randers, Denmark, 8900
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  • Roskilde, Denmark, DK-4000
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  • Slagelse, Denmark, DK-4200
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• France
  • Besancon, France, 25000
    • Local Institution
  • Caen, France, 14033
    • Local Institution
  • Chambray-les-Tours, France, 37170
    • Local Institution
  • Le Coudray, France, 28360
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  • Lyon, France, 69365
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  • Marseille, France, 13385
    • Local Institution
  • Nimes, France, 30029
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  • Pau, France, 64000
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  • Pessac, France, 33604
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  • Toulouse, France, 31059
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• Germany
  • Bad Friedrichshall, Germany, 74177
    • Local Institution
  • Bad Homburg, Germany, 61348
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  • Bad Homburg, Germany, 63148
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  • Berlin, Germany, 13353
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  • Berlin, Germany, 12351
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  • Berlin, Germany, 13347
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  • Bielefeld, Germany, 33604
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  • Brandenburg, Germany, 14770
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  • Bremen, Germany, 28277
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  • Chemnitz, Germany, 09111
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  • Dortmund, Germany, 44137
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  • Dresden, Germany, 01067
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  • Dresden, Germany, 01277
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  • Erfurt, Germany, 99089
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  • Erfurt, Germany, 99097
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45122
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  • Frankfurt am Main, Germany, 65929
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  • Freiburg, Germany, 79106
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  • Gottingen, Germany, 37075
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  • Greifswald, Germany, 17475
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  • Hamburg, Germany, 20099
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  • Hamburg, Germany, 22041
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  • Hansestadt Stendal, Germany, 39576
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  • Hennigsdorf, Germany, 16761
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  • Hoyerswerda, Germany, 02977
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  • Jena, Germany, 07747
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  • Karlsbad, Germany, 76307
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  • Kassel, Germany, 34121
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  • Koln, Germany, 50937
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  • Lahr, Germany, 77933
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  • Leipzig, Germany, 04103
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  • Limburg, Germany, 65549
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  • Ludenscheid, Germany, 58515
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  • Luebeck, Germany, 23538
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  • Magdeburg, Germany, 39120
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  • Mainz, Germany, 55131
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  • Mannheim, Germany, 68167
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  • Neuss, Germany, 41464
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  • Papenburg, Germany, 26871
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  • Regensburg, Germany, 93053
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  • Rostock, Germany, 18057
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  • Straubing, Germany, 94315
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  • Tubingen, Germany, 72076
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  • Ulm, Germany, 89077
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  • Villingen-Schwenningen, Germany, 78052
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  • Weiden i.d.OPf., Germany, 92637
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  • Worms, Germany, 67550
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  • Wurzburg, Germany, 97080
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• Hungary
  • Bekescsaba, Hungary, 5900
    • Local Institution
  • Budapest, Hungary, 1125
    • Local Institution
  • Budapest, Hungary, 1097
    • Local Institution
  • Budapest, Hungary, 1027
    • Local Institution
  • Budapest, Hungary, 1087
    • Local Institution
  • Budapest, Hungary, 1096
    • Local Institution
  • Budapest, Hungary, 1134
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  • Keszthely, Hungary, 08360
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  • Mosonmagyarovar, Hungary, 9200
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  • Pecs, Hungary, 7623
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  • Pecs, Hungary, 7624
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  • Szeged, Hungary, 6725
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  • Szekszard, Hungary, 7100
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  • Szolnok, Hungary, 5004
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  • Bacs-kiskun
    • Baja, Bacs-kiskun, Hungary, 6500
      • Local Institution
• India
  • Amritsar, India, 143004
    • Local Institution
  • Jaipur,, India, 302020
    • Local Institution
  • Lucknow, India, 226003
    • Local Institution
  • Madurai, India, 625107
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  • Mangalore, India, 575002
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  • New Delhi, India, 110025
    • Local Institution
  • New Delhi, India, 110060
    • Local Institution
  • Noida, India, 201301
    • Local Institution
  • Shivamogga, India, 577205
    • Local Institution
  • Vadodara, India, 390015
    • Local Institution
  • Vijayawada, India, 520008
    • Local Institution
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Local Institution
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • Local Institution
• Israel
  • Afula, Israel, 18101
    • Local Institution
  • Ashkelon, Israel, 78278
    • Local Institution
  • Hadera, Israel, 38100
    • Local Institution
  • Haifa, Israel, 31096
    • Local Institution
  • Haifa, Israel, 31048
    • Local Institution
  • Haifa, Israel, 34361
    • Local Institution
  • Herzliya, Israel, 46851
    • Local Institution
  • Holon, Israel, 58100
    • Local Institution
  • Jerusalem, Israel, 91240
    • Local Institution
  • Ramat-Gan, Israel, 52621
    • Local Institution
  • Rehovot, Israel, 76100
    • Local Institution
  • Safed, Israel, 13100
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution
  • Tiberias, Israel, 15208
    • Local Institution
• Italy
  • Grosseto, Italy, 58100
    • Local Institution
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Local Institution
  • Changwon, Korea, Republic of, 51353
    • Local Institution
  • Daegu, Korea, Republic of, 42415
    • Local Institution
  • Daegu, Korea, Republic of, 41931
    • Local Institution
  • Daejeon, Korea, Republic of, 35015
    • Local Institution
  • Gwang Ju, Korea, Republic of, 501-757
    • Local Institution
  • Incheon, Korea, Republic of, 21431
    • Local Institution
  • Seongnam-si, Korea, Republic of, 13620
    • Local Institution
  • Seoul, Korea, Republic of, 03080
    • Local Institution
  • Seoul, Korea, Republic of, 138736
    • Local Institution
  • Seoul, Korea, Republic of, 08308
    • Local Institution
  • Seoul, Korea, Republic of, 130-710
    • Local Institution
• Mexico
  • Aguascalientes, Mexico, 20230
    • Local Institution
  • Durango, Mexico, 34080
    • Local Institution
  • Puebla, Mexico, 72197
    • Local Institution
  • San Luis Potosi, Mexico, 78200
    • Local Institution
  • San Luis Potosi, Mexico
    • Local Institution
  • Tlalnepantla De Baz, Mexico, 54055
    • Local Institution
  • Veracruz, Mexico, 91910
    • Local Institution
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • Local Institution
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37150
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Local Institution
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64000
      • Local Institution
  • QUE
    • Queretaro, QUE, Mexico, 76000
      • Local Institution
  • Queretaro
    • San Juan del Rio, Queretaro, Mexico, 76800
      • Local Institution
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80230
      • Local Institution
• Netherlands
  • Amsterdam, Netherlands, 1034 CS
    • Local Institution
  • Amsterdam, Netherlands, 1061 AE
    • Local Institution
  • Arnhem, Netherlands, 6815 AD
    • Local Institution
  • Breda, Netherlands, 4819 EV
    • Local Institution
  • Ede, Netherlands, 6716 RP
    • Local Institution
  • Groningen, Netherlands, 9728NT
    • Local Institution
  • Hardenberg, Netherlands, 7772 SE
    • Local Institution
  • Maastricht, Netherlands, 6211 LK
    • Local Institution
  • Nieuwegein, Netherlands, 3435 CM
    • Local Institution
  • Rotterdam, Netherlands, 3045 PM
    • Local Institution
  • Tilburg, Netherlands, 5042 AD
    • Local Institution
  • Uden, Netherlands, 5406 PT
    • Local Institution
• Norway
  • Bod?, Norway, NO-8005
    • Local Institution
  • Oslo, Norway, 0450
    • Local Institution
  • Oslo, Norway, NO-370
    • Local Institution
  • Skien, Norway, N-3710
    • Local Institution
  • Stavanger, Norway, 4068
    • Local Institution
  • Tromso, Norway, 9038
    • Local Institution
• Peru
  • Callao, Peru, Callao 02
    • Local Institution
  • Callao, Peru, CALLAO 2
    • Local Institution
  • Cusco, Peru, Cusco 84
    • Local Institution
  • Lima, Peru, LIMA 11
    • Local Institution
  • Lima, Peru, LIMA 31
    • Local Institution
  • Lima
    • Miraflores, Lima, Peru
      • Local Institution
• Poland
  • Bialystok, Poland, 15-276
    • Local Institution
  • Bydgoszcz, Poland, 85-168
    • Local Institution
  • Bytom, Poland, 41-902
    • Local Institution
  • Chojnice, Poland, 89-600
    • Local Institution
  • Gdynia, Poland, 81-423
    • Local Institution
  • Gdynia, Poland, 81-472
    • Local Institution
  • Katowice, Poland, 40-060
    • Local Institution
  • Kielce, Poland, 25-020
    • Local Institution
  • Krakow, Poland, 31-501
    • Local Institution
  • Krakow, Poland, 31-202
    • Local Institution
  • Krakow, Poland, 30-082
    • Local Institution
  • Lodz, Poland, 91-078
    • Local Institution
  • Lodz, Poland, 91-347
    • Local Institution
  • Lodz, Poland, 92-213
    • Local Institution
  • Lubin, Poland, 59-301
    • Local Institution
  • Opole, Poland, 45-418
    • Local Institution
  • Plock, Poland, 09-402
    • Local Institution
  • Siemianowice Slaskie, Poland, 41-100
    • Local Institution
  • Torun, Poland, 87-100
    • Local Institution
  • Warszawa, Poland, 01-211
    • Local Institution
  • Warszawa, Poland, 04-073
    • Local Institution
  • Wloclawek, Poland, 87-800
    • Local Institution
  • Wroclaw, Poland, 50-981
    • Local Institution
  • Wroclaw, Poland, 50-315
    • Local Institution
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-848
      • Local Institution
• Portugal
  • Almada, Portugal, 2801-951
    • Local Institution
  • Aveiro, Portugal, 3814-501
    • Local Institution
  • Braga, Portugal, 4710-243
    • Local Institution
  • Coimbra, Portugal, 3000-075
    • Local Institution
  • Covilha, Portugal, 6200-251
    • Local Institution
  • Guimar?es, Portugal, 4835-044
    • Local Institution
  • Leiria, Portugal, 2410-187
    • Local Institution
  • Lisbon, Portugal, 1649-035
    • Local Institution
  • Senhora De Hora, Matosinhos, Portugal, 4464-513
    • Local Institution
  • Vila Real, Portugal, 5000-508
    • Local Institution
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Local Institution
• Romania
  • Baia Mare, Romania, 430031
    • Local Institution
  • Brasov, Romania, 500326
    • Local Institution
  • Bucharest, Romania, 022328
    • Local Institution
  • Bucharest, Romania, 050098
    • Local Institution
  • Cluj-Napoca, Romania, 400006
    • Local Institution
  • Cluj-Napoca, Romania, 400347
    • Local Institution
  • Craiova, Romania, 200642
    • Local Institution
  • Oradea, Romania, 410169
    • Local Institution
  • Pitesti, Romania, 110283
    • Local Institution
  • Sibiu, Romania, 550172
    • Local Institution
  • Targoviste, Romania, 130095
    • Local Institution
  • Targu Mures, Romania, 540136
    • Local Institution
  • Timisoara, Romania, 300079
    • Local Institution
  • Timisoara, Romania, 300310
    • Local Institution
  • Tirgu Mures, Romania, 540042
    • Local Institution
• Russian Federation
  • Ekaterinburg, Russian Federation, 620026
    • Local Institution
  • Gatchina, Russian Federation, 188300
    • Local Institution
  • Kazan, Russian Federation, 420103
    • Local Institution
  • Krasnodar, Russian Federation, 350012
    • Local Institution
  • Krasnodar, Russian Federation, 350086
    • Local Institution
  • Moscow, Russian Federation, 121309
    • Local Institution
  • Moscow, Russian Federation, 111539
    • Local Institution
  • Moscow, Russian Federation, 117292
    • Local Institution
  • Moscow, Russian Federation, 121552
    • Local Institution
  • Novosibirsk, Russian Federation, 630055
    • Local Institution
  • Novosibirsk, Russian Federation, 630047
    • Local Institution
  • Saint Petersburg, Russian Federation, 192242
    • Local Institution
  • Samara, Russian Federation, 443070
    • Local Institution
  • Saratov, Russian Federation, 410028
    • Local Institution
  • Saratov, Russian Federation, 410054
    • Local Institution
  • Sochi, Russian Federation, 354057
    • Local Institution
  • St. Petersburg, Russian Federation, 195257
    • Local Institution
  • St. Petersburg, Russian Federation, 195067
    • Local Institution
  • St. Petersburg, Russian Federation, 196601
    • Local Institution
  • St. Petersburg, Russian Federation, 198013
    • Local Institution
  • St. Petersburg, Russian Federation, 199106
    • Local Institution
  • Tyumen, Russian Federation, 625000
    • Local Institution
  • Tyumen, Russian Federation, 625026
    • Local Institution
• Serbia
  • Belgarde, Serbia, 11000
    • Local Institution
  • Belgrade, Serbia, 11000
    • Local Institution
  • Belgrade, Serbia, 11080
    • Local Institution
  • Nis, Serbia, 18000
    • Local Institution
  • Sremska Kamenica, Serbia, 21204
    • Local Institution
  • Uzice, Serbia, 31000
    • Local Institution
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • Local Institution
  • Bardejov, Slovakia, 085 01
    • Local Institution
  • Bratislava, Slovakia, 813 69
    • Local Institution
  • Bratislava, Slovakia, 833 48
    • Local Institution
  • Brezno, Slovakia, 977 42
    • Local Institution
  • Kosice, Slovakia, 040 01
    • Local Institution
  • Kosice, Slovakia, 040 11
    • Local Institution
  • Kosice, Slovakia, 040 22
    • Local Institution
  • Nitra, Slovakia, 950 01
    • Local Institution
  • Spisska Nova Ves, Slovakia, 052 01
    • Local Institution
  • Trebisov, Slovakia, 075 01
    • Local Institution
  • Trencin, Slovakia, 911 01
    • Local Institution
• Spain
  • Alicante, Spain, ?03010
    • Local Institution
  • Barcelona, Spain, 08036
    • Local Institution
  • Cordoba, Spain, 14004
    • Local Institution
  • Huelva, Spain, 21005
    • Local Institution
  • Madrid, Spain, 28034
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Madrid, Spain, 28040
    • Local Institution
  • Madrid, Spain, 28031
    • Local Institution
  • Malaga, Spain, 29010
    • Local Institution
  • Marbella, Spain, 29603
    • Local Institution
  • Palma de Mallorca, Spain, 07198
    • Local Institution
  • San Sebastian, Spain, 20080
    • Local Institution
  • Valencia, Spain, 46014
    • Local Institution
  • Valencia, Spain, 46010
    • Local Institution
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Local Institution
• Sweden
  • Eskilstuna, Sweden, 63188
    • Local Institution
  • Goteborg, Sweden, 413 45
    • Local Institution
  • Jonkoping, Sweden, 551 85
    • Local Institution
  • Ostersund, Sweden, SE-83183
    • Local Institution
  • Skelleftea, Sweden, 931 81
    • Local Institution
  • Stockholm, Sweden, 112 81
    • Local Institution
  • Uppsala, Sweden, 755 92
    • Local Institution
• Switzerland
  • Bern, Switzerland, 3010
    • Local Institution
  • Geneva, Switzerland, 1205
    • Local Institution
  • Winterthur, Switzerland, 8401
    • Local Institution
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Local Institution
  • Chernivtsi, Ukraine, 58013
    • Local Institution
  • Dnipropetrovsk, Ukraine, 49006
    • Local Institution
  • Ivano-Frankivsk, Ukraine, 76018
    • Local Institution
  • Kharkiv, Ukraine, 61058
    • Local Institution
  • Kharkiv, Ukraine, 61103
    • Local Institution
  • Kharkiv, Ukraine, 61176
    • Local Institution
  • Kyiv, Ukraine, 03680
    • Local Institution
  • Kyiv, Ukraine, 02091
    • Local Institution
  • Kyiv, Ukraine, 03049
    • Local Institution
  • Lutsk, Ukraine, 43005
    • Local Institution
  • Lutsk, Ukraine, 43024
    • Local Institution
  • Mykolaiv, Ukraine, 54003
    • Local Institution
  • Odesa, Ukraine, 65014
    • Local Institution
  • Uzhhorod, Ukraine, 88014
    • Local Institution
  • Vinnytsia, Ukraine, 21005
    • Local Institution
  • Vinnytsia, Ukraine, 21029
    • Local Institution
  • Zhaporizhzhya, Ukraine, 69000
    • Local Institution
• United Kingdom
  • Birmingham, United Kingdom, B18 7QH
    • Local Institution
  • Dudley, West Midlands, United Kingdom, DY1 2HQ
    • Local Institution
  • Dundee, United Kingdom, DD1 9SY
    • Local Institution
  • Wolverhampton, United Kingdom, WV10 0QP
    • Local Institution
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Local Institution
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • Local Institution
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Local Institution
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L14 3PE
      • Local Institution
  • Northamptonshire
    • Northampton, Northamptonshire, United Kingdom, NN1 5BD
      • Local Institution
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Local Institution
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3410
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35243
      • Cardiovascular Associates of the Southeast, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Arizona Heart Rhythm Center
    • Phoenix, Arizona, United States, 85054
      • Local Institution
    • Scottsdale, Arizona, United States, 85251
      • Scottsdale Osborn Medical Center
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Local Institution
    • Phoenix, Arkansas, United States, 85015
      • Local Institution
  • California
    • Alhambra, California, United States, 91801
      • Comprehensive Cardiovascular Specialists
    • Culver City, California, United States, 90230
      • Local Institution
    • Fremont, California, United States, 94536
      • Washington Township Medical Foundation
    • Huntington Beach, California, United States, 92648
      • California Heart Specialist, Inc.
    • La Jolla, California, United States, 92037
      • Foundation for Cardiovascular Medicine
    • Long Beach, California, United States, 90806
      • Local Institution
    • Rancho Mirage, California, United States, 92270
      • Local Institution
    • San Diego, California, United States, 92161
      • Local Institution
    • Stockton, California, United States, 95204
      • Manshadi Heart Institute
    • Torrance, California, United States, 90502
      • Local Institution
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Local Institution
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Local Institution
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Orlando Heart Specialists
    • Bradenton, Florida, United States, 34209
      • Local Institution
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular and Interventional Consultants
    • Clearwater, Florida, United States, 33756
      • Local Institution
    • Daytona Beach, Florida, United States, 32114
      • Daytona Heart Group
    • Fort Lauderdale, Florida, United States, 33316
      • Local Institution
    • Jacksonville, Florida, United States, 32204
      • Local Institution
    • Jacksonville, Florida, United States, 32216
      • Local Institution
    • Jacksonville Beach, Florida, United States, 32250
      • Local Institution
    • Jupiter, Florida, United States, 33458
      • Tenet Florida Physician Services
    • Lake Mary, Florida, United States, 32746
      • Local Institution
    • Miami, Florida, United States, 33173
      • Local Institution
    • Ocala, Florida, United States, 34471
      • Mediquest Research
    • Orlando, Florida, United States, 32825
      • Local Institution
    • Palm Beach Gardens, Florida, United States, 33410
      • CP Cardiology Partners
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront Health St. Petersburg
    • Tampa, Florida, United States, 33613
      • Local Institution
    • Wellington, Florida, United States, 33449
      • Cardiology Partners
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens Regional Cariology Group
    • Atlanta, Georgia, United States, 30342
      • Local Institution
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Covington, Georgia, United States, 30014
      • Georgia Heart Specialists
    • Cumming, Georgia, United States, 30041
      • Local Institution
    • Tucker, Georgia, United States, 30084
      • Local Institution
  • Idaho
    • Boise, Idaho, United States, 83712
      • Saint Lukes Idaho Cardiology Associates
  • Illinois
    • Fairview Heights, Illinois, United States, 62208
      • Medicoricium, LLC
    • Jerseyville, Illinois, United States, 62052
      • Gateway Cardiology PC
    • Normal, Illinois, United States, 61761
      • Advocate Medical Group ? Cardiology and Pulmonology
    • Olympia Fields, Illinois, United States, 60461
      • South Suburban Cardiology
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • Local Institution
    • Elkhart, Indiana, United States, 46514
      • Elkhart Clinic LLC
    • Indianapolis, Indiana, United States, 46202
      • Roudebush VA Medical Center
    • Richmond, Indiana, United States, 47374
      • Reid Hospital and Health Care Services
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Stead Family Children's Hospital
    • Waterloo, Iowa, United States, 50702
      • Northeast Iowa Family Practice Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Local Institution
    • Wichita, Kansas, United States, 67203
      • Local Institution
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Saint Elizabeth Healthcare
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health
    • Minden, Louisiana, United States, 71055
      • Local Institution
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America LA LLC - PPDS
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Local Institution
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Great Lakes Heart Center Of Alpena
    • Ann Arbor, Michigan, United States, 48109
      • Local Institution
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48202
      • Local Institution
    • Lansing, Michigan, United States, 48912
      • Local Institution
    • Saginaw, Michigan, United States, 48602
      • Covenant Center for the Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55433-4568
      • Metropolitan Cardiology Consultants
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
    • Jackson, Mississippi, United States, 39216
      • Local Institution
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research LLC
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Cardiovascular Specialists
    • Columbia, Missouri, United States, 65212
      • Local Institution
    • Joplin, Missouri, United States, 64804
      • Freeman Health System
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
    • Saint Louis, Missouri, United States, 63128
      • Gateway Cardiology PC
    • Springfield, Missouri, United States, 65807
      • Cox Health Systems
  • Montana
    • Billings, Montana, United States, 59101
      • Local Institution
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • HCP Clinical Research LLC
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center.
  • New Jersey
    • Linden, New Jersey, United States, 07036
      • New Jersey Heart
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates
    • Brooklyn, New York, United States, 11215
      • New York-Presbyterian Brooklyn Methodist Hospital
    • Brooklyn, New York, United States, 11217
      • Local Institution
    • Buffalo, New York, United States, 14215
      • Buffalo Heart Group LLP
    • New York, New York, United States, 10025
      • Mount Sinai-St. Lukes
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Cardiovascular Practice, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Cardiology Associates PA
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina School of Medicine
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
    • Lenoir, North Carolina, United States, 28645
      • Clinical Trials of America-NC, LLC - PPDS
    • Lumberton, North Carolina, United States, 28358
      • Duke Cardiology and Cardiovascular Surgery of Lumberton
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Columbus, Ohio, United States, 43214
      • Local Institution
    • Kettering, Ohio, United States, 45429
      • Local Institution
    • Willoughby, Ohio, United States, 44094
      • Local Institution
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16544
      • Saint Vincent Hospital
    • Lancaster, Pennsylvania, United States, 17603
      • Heart Group
    • Newton, Pennsylvania, United States, 18940
      • Mercer Bucks Cardiology
    • York, Pennsylvania, United States, 17405
      • WellSpan York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Heart
    • Greenville, South Carolina, United States, 29607
      • Upstate Cardiology PA
    • North Charleston, South Carolina, United States, 29418
      • Roper St. Francis Healthcare
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Cardiology Clinical Research Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Local Institution
    • Jackson, Tennessee, United States, 38301
      • Research Associates Of Jackson
    • Knoxville, Tennessee, United States, 37917
      • Cardiovascular Research of Knoxville
    • Knoxville, Tennessee, United States, 37934
      • Knoxville Health Managment Associates Cardiology PPM LLC
    • Oak Ridge, Tennessee, United States, 37830
      • Parkway Cardiology Associates PC
  • Texas
    • Austin, Texas, United States, 78705
      • Local Institution
    • Austin, Texas, United States, 78758
      • Local Institution
    • Dallas, Texas, United States, 75216
      • Local Institution
    • Fort Sam Houston, Texas, United States, 78234
      • San Antonio Military Medical Center
    • Houston, Texas, United States, 77025
      • Angiocardiac Care of Texas PA
    • Houston, Texas, United States, 77084
      • Local Institution
    • Houston, Texas, United States, 77089
      • Local Institution
    • Huntsville, Texas, United States, 77340
      • Grace Research, LLC
    • Huntsville, Texas, United States, 77340
      • Local Institution
    • Katy, Texas, United States, 77450
      • Local Institution
    • Lubbock, Texas, United States, 79410
      • Caprock Cardiac Center Research Institute
    • Plano, Texas, United States, 75024
      • Local Institution
    • San Antonio, Texas, United States, 78229
      • Local Institution
    • San Antonio, Texas, United States, 78229
      • Mercury Medical LLC
    • Sealy, Texas, United States, 77474
      • Local Institution
    • Sugar Land, Texas, United States, 77479
      • Local Institution
    • Victoria, Texas, United States, 77901
      • Victoria Heart and Vascular Center
  • Vermont
    • Burlington, Vermont, United States, 05403
      • University of Vermont
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Virginia Heart
    • Leesburg, Virginia, United States, 20176
      • Virginia Heart Group Ltd
    • Richmond, Virginia, United States, 23235
      • CJW Medical Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St Mary's Medical Center
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute
• Virgin Islands (U.S.)
  • Christiansted, Virgin Islands (U.S.), 00820
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
• Planned use of antiplatelet agents for at least 1 to 6 months
• Males and Females ≥ 18 years of age
• Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

• Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
• Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
• Patients with a history of intracranial hemorrhage
• Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
• Patients with known ongoing bleeding and patients with known coagulopathies
• Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Apixaban; 5 mg or 2.5 mg Apixaban tablets orally twice per day	Drug: Apixaban; Other Names: BMS-562247
Active Comparator: Vitamin K Antagonist; VKA tablets orally once daily	Drug: vitamin K antagonist
Placebo Comparator: Acetylsalicylic acid film coated tablet; 81 mg Acetylsalicylic acid film coated tablet orally once daily	Drug: Acetylsalicylic acid; Other Names: Aspirin 81 mg
Placebo Comparator: Placebo matching Acetylsalicylic acid film coated tablet; Placebo matching Acetylsalicylic acid film coated tablet once daily	Other: Acetylsalicylic acid placebo; Other Names: aspirin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period	Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period	Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA	Time to first occurrence during the time the participants were treated with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA	Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin	Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA	Time to first occurrence during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin	Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Pfizer; Duke Clinical Research Institute

Publications and helpful links

General Publications

• Bahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166.
• Welsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892.
• Harskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035.
• Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.
• Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.
• Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available.
• Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrom T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabate M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.
• Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.
• Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 x 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2015
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): November 10, 2018

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Arrhythmias, Cardiac; Syndrome; Atrial Fibrillation; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Aspirin; Vitamin K; Apixaban
• Other Study ID Numbers: CV185-316; 2014-002004-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No