A Phase III Study of Apixaban in Patients With Atrial Fibrillation (AVERROES)

May 16, 2018 updated by: Bristol-Myers Squibb

Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

Study Type

Interventional

Enrollment (Actual)

6421

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 Locations

  • Argentina
      • Buenos Aires, Argentina, 1221
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
      • Cordoba, Argentina, 5016
        • Local Institution
      • Cordoba, Argentina, X5000AAX
        • Local Institution
      • Cordoba, Argentina, X5000EPU
        • Local Institution
      • Cordoba, Argentina, X5000EVQ
        • Local Institution
      • Cordoba, Argentina, X5009BSN
        • Local Institution
      • Corrientes, Argentina, 3400
        • Local Institution
      • Salta, Argentina, A4406CLA
        • Local Institution
      • Santa Fe, Argentina, 3000
        • Local Institution
    • Buenos Aires
      • Adrogue, Buenos Aires, Argentina, 1846
        • Local Institution
      • Autonoma Buenos Aires, Buenos Aires, Argentina, C1119ACN
        • Local Institution
      • Bahia Blanca, Buenos Aires, Argentina, B8000FTD
        • Local Institution
      • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
        • Local Institution
      • Haedo, Buenos Aires, Argentina, B1706AJU
        • Local Institution
      • La Plata, Buenos Aires, Argentina, B1902COS
        • Local Institution
      • La Plata, Buenos Aires, Argentina, B1900AXI
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina, B7600FZN
        • Local Institution
      • Merlo, Buenos Aires, Argentina, B1722COV
        • Local Institution
      • Ramos Mejia, Buenos Aires, Argentina, B1704ETD
        • Local Institution
    • Cordoba
      • San Francisco, Cordoba, Argentina, X2400MHC
        • Local Institution
    • Jujuy
      • San Salvador De Jujuy, Jujuy, Argentina, Y4600ABF
        • Local Institution
    • Provincia Buenos Aires
      • Zarate, Provincia Buenos Aires, Argentina, B2800DGH
        • Local Institution
    • Santa FE
      • Rosario, Santa FE, Argentina, 2000
        • Local Institution
      • Rosario, Santa FE, Argentina, S2000CVB
        • Local Institution
      • Rosario, Santa FE, Argentina, S2001ODA
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
        • Local Institution
      • San Miguel De Tucuman, Tucuman, Argentina, T4000ICL
        • Local Institution
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Local Institution
      • Concord, New South Wales, Australia, 2139
        • Local Institution
      • Gosford, New South Wales, Australia, 2250
        • Local Institution
      • Kingswood, New South Wales, Australia, 2747
        • Local Institution
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Local Institution
      • Kippa Ring, Queensland, Australia, 4021
        • Local Institution
      • Milton, Queensland, Australia, 4064
        • Local Institution
      • Woolloongabba, Queensland, Australia, 4102
        • Local Institution
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Local Institution
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Linz, Austria, 4020
        • Local Institution
      • Oberpullendorf, Austria, 7350
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
  • Belgium
      • Aalst, Belgium, 9300
        • Local Institution
      • Brasschaat, Belgium, 2930
        • Local Institution
      • Brussel, Belgium, 1090
        • Local Institution
      • Bruxelles, Belgium, 1070
        • Local Institution
      • De Pinte, Belgium, 9840
        • Local Institution
      • Genk, Belgium, 3600
        • Local Institution
      • Huy, Belgium, 4500
        • Local Institution
      • Roeselare, Belgium, 8800
        • Local Institution
      • Turnhout, Belgium, 2300
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil, 20551
        • Local Institution
      • Sao Paulo, Brazil, 05403
        • Local Institution
      • Sao Paulo, Brazil, 04012
        • Local Institution
      • Sao Paulo, Brazil, 040112-180
        • Local Institution
      • Sao Paulo, Brazil, 04038
        • Local Institution
    • Bahia
      • Salvador, Bahia, Brazil, 40144
        • Local Institution
      • Salvador, Bahia, Brazil, 41810
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150
        • Local Institution
      • Uberaba, Minas Gerais, Brazil, 38010
        • Local Institution
      • Uberaba, Minas Gerais, Brazil, 38025
        • Local Institution
    • Para
      • Belem, Para, Brazil, 66087
        • Local Institution
    • Parana
      • Campina Grande Do Sul, Parana, Brazil, 83430
        • Local Institution
      • Curitiba, Parana, Brazil, 80010
        • Local Institution
      • Curitiba, Parana, Brazil, 80730
        • Local Institution
      • Maringa, Parana, Brazil, 87015
        • Local Institution
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59020
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90620
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350
        • Local Institution
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010
        • Local Institution
      • Sao Jose, Santa Catarina, Brazil, 88103
        • Local Institution
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18600
        • Local Institution
      • Campinas, Sao Paulo, Brazil, 13059
        • Local Institution
      • Marilia, Sao Paulo, Brazil, 17519
        • Local Institution
      • Marilia, Sao Paulo, Brazil, 17515
        • Local Institution
      • San Jose- Do Rio Preto, Sao Paulo, Brazil, 15015
        • Local Institution
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015
        • Local Institution
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
        • Local Institution
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15025
        • Local Institution
  • Canada
      • Quebec, Canada, G1J 1Z6
        • Local Institution
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Local Institution
    • Ontario
      • Brampton, Ontario, Canada, L6W 2X7
        • Local Institution
      • Burlington, Ontario, Canada, L7M 4Y1
        • Local Institution
      • Cambridge, Ontario, Canada, N1R 7R1
        • Local Institution
      • Cambridge, Ontario, Canada, N1R 6V6
        • Local Institution
      • Grimsby, Ontario, Canada, L3M 1P3
        • Local Institution
      • Hamilton, Ontario, Canada, L8L 2X2
        • Local Institution
      • Hamilton, Ontario, Canada, L8M 1K7
        • Local Institution
      • Oshawa, Ontario, Canada, L1H 1B9
        • Local Institution
      • Oshawa,, Ontario, Canada, L1J 2J9
        • Local Institution
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Local Institution
      • Sarnia, Ontario, Canada, N7T 4X3
        • Local Institution
      • Sudbury, Ontario, Canada, P3C 5K7
        • Local Institution
      • Sudbury, Ontario, Canada, P3E 2N8
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution
      • Toronto, Ontario, Canada, M5B 1W8
        • Local Institution
      • Weston, Ontario, Canada, M9N 1W4
        • Local Institution
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Local Institution
      • Montreal, Quebec, Canada, H1T 1C8
        • Local Institution
      • Montreal, Quebec, Canada, H2K 4L5
        • Local Institution
      • Montreal, Quebec, Canada, H2W 1T8
        • Local Institution
      • Saint Georges Beauce, Quebec, Canada, G5Y 4W1
        • Local Institution
      • St. Jerome, Quebec, Canada, J7Z 5T3
        • Local Institution
      • St. Lambert, Quebec, Canada, J4P 2H4
        • Local Institution
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Local Institution
      • Westmount, Quebec, Canada, H3Z 2M6
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7L OY7
        • Local Institution
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4781173
        • Local Institution
      • Victoria, Araucania, Chile, 4720000
        • Local Institution
    • LOS Lagos
      • Osorno, LOS Lagos, Chile
        • Local Institution
    • Los Rios
      • Valdivia, Los Rios, Chile, 5111847
        • Local Institution
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7600448
        • Local Institution
      • Santiago, Metropolitana, Chile, 7500520
        • Local Institution
      • Santiago, Metropolitana, Chile, 8330074
        • Local Institution
      • Santiago, Metropolitana, Chile, 8360160
        • Local Institution
      • Santiago, Metropolitana, Chile, 8900085
        • Local Institution
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2570017
        • Local Institution
  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Local Institution
      • Beijing, Beijing, China, 100029
        • Local Institution
      • Beijing, Beijing, China, 100020
        • Local Institution
      • Beijing, Beijing, China, 100037
        • Local Institution
      • Beijing, Beijing, China, 100038
        • Local Institution
      • Beijing, Beijing, China, 100088
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Local Institution
    • Hebei
      • Shijiazhuang, Hebei, China, 050082
        • Local Institution
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Local Institution
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Local Institution
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Local Institution
      • Shenyang, Liaoning, China, 110001
        • Local Institution
    • Shandong
      • Qingdao, Shandong, China, 266071
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution
      • Shanghai, Shanghai, China, 200433
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
  • Colombia
      • Bogota, Colombia
        • Local Institution
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Local Institution
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Local Institution
    • Santander
      • Bucaramanga, Santander, Colombia
        • Local Institution
    • Valle DEL Cauca
      • Cali, Valle DEL Cauca, Colombia
        • Local Institution
  • Czechia
      • Brno, Czechia, 656 91
        • Local Institution
      • Havirov - Mesto, Czechia, 736 01
        • Local Institution
      • Jindrichuv Hradec, Czechia, 377 38
        • Local Institution
      • Kladno, Czechia, 272 59
        • Local Institution
      • Kromeriz, Czechia, 767 55
        • Local Institution
      • Mestec Kralove, Czechia, 289 03
        • Local Institution
      • Ostrava, Czechia, 702 00
        • Local Institution
      • Pisek, Czechia, 397 01
        • Local Institution
      • Praha 1, Czechia, 110 00
        • Local Institution
      • Praha 2, Czechia, 128 08
        • Local Institution
      • Praha 5, Czechia, 150 00
        • Local Institution
      • Prelouc, Czechia, 535 01
        • Local Institution
      • Pribram, Czechia, 261 26
        • Local Institution
      • Slany, Czechia, 274 01
        • Local Institution
      • Usti Nad Orlici, Czechia, 562 18
        • Local Institution
  • Denmark
      • Arhus C, Denmark, 8000
        • Local Institution
      • Esbjerg, Denmark, 6700
        • Local Institution
      • Frederiksberg, Denmark, 2000
        • Local Institution
  • Finland
      • Espoo, Finland, 02740
        • Local Institution
      • Helsinki, Finland, 00029 HUS
        • Local Institution
      • Jyvaskyla, Finland, 40100
        • Local Institution
      • Kuopio, Finland, FI-70100
        • Local Institution
      • Tampere, Finland, 33900
        • Local Institution
  • France
      • Abbeville Cedex, France, 80142
        • Local Institution
      • Albi Cedex 09, France, 81013
        • Local Institution
      • Cholet, France, 49325
        • Local Institution
      • Grenoble Cedex 09, France, 38043
        • Local Institution
      • Langres Cedex, France, 52206
        • Local Institution
      • Paris Cedex 18, France, 75018
        • Local Institution
      • Sisteron, France, 04203
        • Local Institution
      • Toulon Cedex 09, France, 83041
        • Local Institution
  • Germany
      • Berlin, Germany, 13353
        • Local Institution
      • Berlin, Germany, 10117
        • Local Institution
      • Berlin, Germany, 12099
        • Local Institution
      • Bonn, Germany, 53115
        • Local Institution
      • Essen, Germany, 45147
        • Local Institution
      • Frankfurt Am Main, Germany, 60590
        • Local Institution
      • Halle/saale, Germany, 06097
        • Local Institution
      • Hamburg, Germany, 22299
        • Local Institution
      • Hamburg, Germany, 22291
        • Local Institution
      • Hamburg, Germany, 22527
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Heidelberg, Germany, 69115
        • Local Institution
      • Kassel, Germany, 34121
        • Local Institution
      • Koln, Germany, 51067
        • Local Institution
      • Leipzig, Germany, 04104
        • Local Institution
      • Magdeburg, Germany, 39112
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Mainz, Germany, 55116
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Papenburg, Germany, 26871
        • Local Institution
      • Regensburg, Germany, 93053
        • Local Institution
      • Riesa, Germany, 01587
        • Local Institution
      • Witten, Germany, 58455
        • Local Institution
      • Wolmirstedt, Germany, 39326
        • Local Institution
  • Greece
      • Athens, Greece, 151 23
        • Local Institution
      • Larissa, Greece, 41 221
        • Local Institution
      • Thiva, Greece, 32200
        • Local Institution
  • Hong Kong
      • Chai Wan, Hong Kong
        • Local Institution
      • Hong Kong, Hong Kong
        • Local Institution
    • NEW Territories
      • Shatin, NEW Territories, Hong Kong
        • Local Institution
  • India
      • Ahmedabad, India, 380060
        • Local Institution
      • Bangalore, India, 560034
        • Local Institution
      • Bikaner, India, 334 003
        • Local Institution
      • Indore, India, 452001
        • Local Institution
      • Jaipur, India, 302001
        • Local Institution
      • Kottayam, India, 686016
        • Local Institution
      • Pune, India, 411030
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500001
        • Local Institution
    • Karnataka
      • Bangalore, Karnataka, India, 560052
        • Local Institution
      • Banglore, Karnataka, India, 560054
        • Local Institution
      • Mysore, Karnataka, India, 570020
        • Local Institution
    • Maharashtra
      • Mumbai, Maharashtra, India, 400007
        • Local Institution
      • Mumbai, Maharashtra, India, 400052
        • Local Institution
      • Nagpur,, Maharashtra, India, 440012
        • Local Institution
      • Nashik, Maharashtra, India, 422002
        • Local Institution
      • Pune, Maharashtra, India, 411001
        • Local Institution
    • Nagpur
      • Dhantoli, Nagpur, India, 440012
        • Local Institution
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600081
        • Local Institution
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Local Institution
  • Indonesia
      • Bandung, Indonesia, 40161
        • Local Institution
      • Denpasar, Indonesia, 80114
        • Local Institution
      • Jakarta, Indonesia, 10430
        • Local Institution
      • Jakarta, Indonesia, 13310
        • Local Institution
      • Jakarta Timur, Indonesia, 13750
        • Local Institution
      • Padang, Indonesia, 25137
        • Local Institution
      • Palembang, Indonesia, 30126
        • Local Institution
      • Surabaya, Indonesia, 60286
        • Local Institution
      • Yogyakarta, Indonesia, 55284
        • Local Institution
    • Jawa-timur
      • Malang, Jawa-timur, Indonesia, 65111
        • Local Institution
  • Israel
      • Afula, Israel, 18101
        • Local Institution
      • Ashkelon, Israel, 78278
        • Local Institution
      • Givatayim, Israel, 53583
        • Local Institution
      • Hadera, Israel, 38100
        • Local Institution
      • Haifa, Israel, 31096
        • Local Institution
      • Haifa, Israel, 34362
        • Local Institution
      • Holon, Israel, 58100
        • Local Institution
      • Nazareth, Israel, 16100
        • Local Institution
      • Nazareth, Israel, 16000
        • Local Institution
      • Petach-tikva, Israel, 49100
        • Local Institution
      • Safed, Israel, 13100
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
  • Italy
      • Ascoli Piceno, Italy, 63100
        • Local Institution
      • Chieti, Italy, 66013
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Isernia, Italy, 86170
        • Local Institution
      • Lido Di Camaiore, Italy, 55043
        • Local Institution
      • Palermo, Italy, 90127
        • Local Institution
      • Perugia, Italy, 06126
        • Local Institution
      • San Daniele De Friuli (ud), Italy, 33038
        • Local Institution
      • Sassari, Italy, 07100
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Local Institution
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Daejeon, Korea, Republic of, 302-718
        • Local Institution
      • Gwangju, Korea, Republic of, 501-757
        • Local Institution
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Seoul, Korea, Republic of, 143-729
        • Local Institution
      • Seoul, Korea, Republic of, 130-709
        • Local Institution
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-773
        • Local Institution
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Local Institution
    • Kyunggi-do
      • Kuri-city, Kyunggi-do, Korea, Republic of, 471-701
        • Local Institution
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Local Institution
      • Kuala Lumpur, Malaysia, 59100
        • Local Institution
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Local Institution
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Local Institution
    • Pinang
      • Pulau Pinang, Pinang, Malaysia, 10990
        • Local Institution
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Local Institution
      • Aguascalientes, Mexico, 20127
        • Local Institution
      • Chihuahua, Mexico, 31203
        • Local Institution
      • Durango, Mexico, 34080
        • Local Institution
      • Queretaro, Mexico, 76000
        • Local Institution
      • San Luis Potosi, Mexico, 78200
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
      • Mexico, Distrito Federal, Mexico, 06726
        • Local Institution
    • Estado De Mexico
      • Atizapan De Zaragoza, Estado De Mexico, Mexico, 52975
        • Local Institution
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39570
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44600
        • Local Institution
      • Zapopan, Jalisco, Mexico, 45200
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64240
        • Local Institution
    • San Luis Potosi
      • San Luis Potosi, Slp, San Luis Potosi, Mexico, 78240
        • Local Institution
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
        • Local Institution
    • Sonora
      • Hermosillo, Sonora, Mexico, 83190
        • Local Institution
    • Veracruz
      • Jalapa, Veracruz, Mexico, 91020
        • Local Institution
  • Norway
      • Fyllingsdal, Norway, 5145
        • Local Institution
      • Kongsberg, Norway, 3602
        • Local Institution
      • Oslo, Norway, 0450
        • Local Institution
      • Oslo, Norway, 0264
        • Local Institution
  • Philippines
      • Cagayan De Oro City, Philippines, 9000
        • Local Institution
      • Cavite, Philippines, 4114
        • Local Institution
      • Laoag City, Philippines, 2900
        • Local Institution
      • Manila, Philippines, 1000
        • Local Institution
      • Muntinlupa City, Philippines, 1780
        • Local Institution
    • Camarines SUR
      • Naga City, Camarines SUR, Philippines, 4400
        • Local Institution
    • Laguna
      • Binan, Laguna, Philippines, 4024
        • Local Institution
    • Lanao DEL Norte
      • Iligan City, Lanao DEL Norte, Philippines, 9200
        • Local Institution
  • Poland
      • Czestochowa, Poland, 42-200
        • Local Institution
      • Elblag, Poland, 82-300
        • Local Institution
      • Gdynia, Poland, 81-423
        • Local Institution
      • Gliwice, Poland, 44-100
        • Local Institution
      • Gniewkowo, Poland, 88-140
        • Local Institution
      • Grodzisk Mazowiecki, Poland, 05-825
        • Local Institution
      • Inowroclaw, Poland, 88-100
        • Local Institution
      • Kielce, Poland, 25-736
        • Local Institution
      • Krakow, Poland, 31-501
        • Local Institution
      • Krakow, Poland, 30-092
        • Local Institution
      • Lodz, Poland, 91-302
        • Local Institution
      • Piotrkow Trybunalski, Poland, 97-300
        • Local Institution
      • Plock, Poland, 09-402
        • Local Institution
      • Poznan, Poland, 60-539
        • Local Institution
      • Pulawy, Poland, 24-100
        • Local Institution
      • Siemianowice Slaskie, Poland, 41-100
        • Local Institution
      • Skierniewice, Poland, 96-100
        • Local Institution
      • Tarnow, Poland, 33-100
        • Local Institution
      • Warsaw, Poland, 00-217
        • Local Institution
      • Warszawa, Poland, 04-073
        • Local Institution
      • Warszawa, Poland, 03-242
        • Local Institution
      • Wegrow, Poland, 07-100
        • Local Institution
      • Zabrze, Poland, 41-800
        • Local Institution
      • Zarow, Poland, 58-130
        • Local Institution
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • Local Institution
      • Chelyabinsk, Russian Federation, 454136
        • Local Institution
      • Ekaterinburg, Russian Federation, 620109
        • Local Institution
      • Ekaterinburg, Russian Federation, 620144
        • Local Institution
      • Kazan, Russian Federation, 420012
        • Local Institution
      • Kemerovo, Russian Federation, 650002
        • Local Institution
      • Krasnodar, Russian Federation, 350042
        • Local Institution
      • Moscow, Russian Federation, 125367
        • Local Institution
      • Moscow, Russian Federation, 109240
        • Local Institution
      • Moscow, Russian Federation, 111539
        • Local Institution
      • Moscow, Russian Federation, 121552
        • Local Institution
      • Moscow, Russian Federation, 129336
        • Local Institution
      • Moscow, Russian Federation, 125284
        • Local Institution
      • Moscow, Russian Federation, 127644
        • Local Institution
      • Moscow, Russian Federation, 101990
        • Local Institution
      • Moscow, Russian Federation, 105066
        • Local Institution
      • Moscow, Russian Federation, 117485
        • Local Institution
      • Moscow, Russian Federation, 119121
        • Local Institution
      • Moscow, Russian Federation, 121356
        • Local Institution
      • Moscow, Russian Federation, 129301
        • Local Institution
      • Moscow, Russian Federation, 143000
        • Local Institution
      • Nizhniy Novgorod, Russian Federation, 603035
        • Local Institution
      • Novosibirsk, Russian Federation, 630047
        • Local Institution
      • Perm, Russian Federation, 614097
        • Local Institution
      • Perm, Russian Federation, 614107
        • Local Institution
      • Ryazan, Russian Federation, 390026
        • Local Institution
      • Saint Petersburg, Russian Federation, 193079
        • Local Institution
      • Saint-petersburg, Russian Federation, 190000
        • Local Institution
      • Saint-petersburg, Russian Federation, 191025
        • Local Institution
      • Saint-petersburg, Russian Federation, 193144
        • Local Institution
      • Saint-petersburg, Russian Federation, 194156
        • Local Institution
      • Saint-petersburg, Russian Federation, 194291
        • Local Institution
      • Samara, Russian Federation, 443070
        • Local Institution
      • Samara, Russian Federation, 443095
        • Local Institution
      • Saratov, Russian Federation, 410028
        • Local Institution
      • Saratov, Russian Federation, 410054
        • Local Institution
      • St.petersburg, Russian Federation, 195112
        • Local Institution
      • St.petersburg, Russian Federation, 197198
        • Local Institution
      • Tomsk, Russian Federation, 634012
        • Local Institution
      • Tumen, Russian Federation, 625023
        • Local Institution
      • Tver, Russian Federation, 170036
        • Local Institution
      • Yaroslavl, Russian Federation, 150062
        • Local Institution
    • Anenki
      • Kaluga, Anenki, Russian Federation, 248007
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 529889
        • Local Institution
      • Singapore, Singapore, 169609
        • Local Institution
      • Singapore, Singapore, 768828
        • Local Institution
  • South Africa
      • Pretoria, South Africa, 0041
        • Local Institution
    • FREE State
      • Bloemfontein, FREE State, South Africa, 9301
        • Local Institution
      • Bloemfontein, FREE State, South Africa, 9300
        • Local Institution
    • Gauteng
      • Alberton, Gauteng, South Africa, 1450
        • Local Institution
    • Western CAPE
      • Bellville, Cape Town, Western CAPE, South Africa, 7530
        • Local Institution
      • Cape Town, Western CAPE, South Africa, 7925
        • Local Institution
      • Somerset West, Western CAPE, South Africa, 7130
        • Local Institution
      • Worcester, Western CAPE, South Africa, 6850
        • Local Institution
  • Spain
      • Albacete, Spain, 02006
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Valencia, Spain, 46017
        • Local Institution
    • Alicante
      • Torrevieja, Alicante, Spain, 03186
        • Local Institution
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Local Institution
    • Galicia
      • Lugo, Galicia, Spain, 27003
        • Local Institution
  • Sweden
      • Goteborg, Sweden, 416 85
        • Local Institution
      • Goteborg, Sweden, 417 17
        • Local Institution
      • Molndal, Sweden, 431 80
        • Local Institution
      • Stockholm, Sweden, 141 86
        • Local Institution
      • Stockholm, Sweden, 111 57
        • Local Institution
      • Stockholm, Sweden, 118 83
        • Local Institution
      • Uppsala, Sweden, 751 85
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 10507
        • Local Institution
      • Taipei, Taiwan, 111
        • Local Institution
      • Taipei, Taiwan, 220
        • Local Institution
  • Turkey
      • Isparta, Turkey, 32100
        • Local Institution
      • Istanbul, Turkey, 34390
        • Local Institution
      • Istanbul, Turkey, 34304
        • Local Institution
      • Kirikkale, Turkey, 71100
        • Local Institution
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Local Institution
      • Donetsk, Ukraine, 83114
        • Local Institution
      • Kharkiv, Ukraine, 61018
        • Local Institution
      • Kharkiv, Ukraine, 61176
        • Local Institution
      • Kharkiv, Ukraine, 61002
        • Local Institution
      • Kharkiv, Ukraine, 61029
        • Local Institution
      • Kharkiv, Ukraine, 61115
        • Local Institution
      • Kyiv, Ukraine, 03680
        • Local Institution
      • Kyiv, Ukraine, 02091
        • Local Institution
      • Kyiv, Ukraine, 04107
        • Local Institution
      • Kyiv, Ukraine, 01023
        • Local Institution
      • Kyiv, Ukraine, 02660
        • Local Institution
      • Kyiv, Ukraine, 04114
        • Local Institution
  • United Kingdom
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
        • Local Institution
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5BL
        • Local Institution
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Local Institution
      • Romford, Essex, United Kingdom, RM7 0AG
        • Local Institution
    • Fife
      • Kirkcaldy, Fife, United Kingdom, KY2 5AH
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, SW17 ORE
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G11 6NT
        • Local Institution
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • Local Institution
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Local Institution
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
        • Local Institution
    • Nottinghamshire
      • Worksop, Nottinghamshire, United Kingdom, S18 0BD
        • Local Institution
    • Portadown
      • Craigavon, Portadown, United Kingdom, BT63 5QQ
        • Local Institution
    • Renfrewshire
      • Paisley, Renfrewshire, United Kingdom, PA2 9PN
        • Local Institution
    • South Yorkshire
      • Barnsley, South Yorkshire, United Kingdom, S75 2EP
        • Local Institution
    • Stirlingshire
      • Larbert, Stirlingshire, United Kingdom, FK5 4WR
        • Local Institution
    • Tyne And Wear
      • Newcastle Upon, Tyne And Wear, United Kingdom, NE2 4HH
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • Local Institution
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • Local Institution
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Mobile Heart Specialists, PC
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Southwest Heart
    • California
      • Anaheim, California, United States, 92801
        • Cardiology Consultants Of Orange County Med. Group Inc
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente Medical Center, West Los Angeles
      • Palm Springs, California, United States, 92262
        • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
      • Pomona, California, United States, 91767
        • Yogesh K. Paliwal Md
      • Poway, California, United States, 92064
        • San Diego Managed Care Group
      • San Diego, California, United States, 92103
        • University of California, San Diego
      • Santa Rosa, California, United States, 95405
        • Santa Rosa Cardiology
      • Vista, California, United States, 92083
        • North County Internal Medicine
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Cardiology Associates Of New Haven,Pc
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Clearwater, Florida, United States, 33756
        • Research Alliance, Inc.
      • Clearwater, Florida, United States, 33756
        • The Heart & Vascular Institute Of Florida
      • Daytona Beach, Florida, United States, 32114
        • Kim A. Klancke, Md
      • Fort Myers, Florida, United States, 33908
        • The Heart Group Pl
      • Jacksonville, Florida, United States, 32204
        • St. Vincent'S Ambulatory Care, Inc
      • Jacksonville Beach, Florida, United States, 32250
        • Baptist Heart Specialists
      • Melbourne, Florida, United States, 32901
        • Michael F. Lesser, Md, Facc Osler Medical Inc.
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center Of Sarasota
      • Tamarac, Florida, United States, 33321
        • The Broward Heart Group, Pa
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Southeast Regional Research Group
      • Savannah, Georgia, United States, 31406
        • Southeast Regional Research Group
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Fox Valley Clinical Research Center, LLC
      • North Chicago, Illinois, United States, 60064
        • North Chicago VA Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Care Group, Llc
      • Indianapolis, Indiana, United States, 46237
        • Indiana Heart Physicians, Inc.
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, Pa
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Dr. Jeffrey Chen
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Peninsula Cardiology Associates, P.A.
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • Pentucket Medical Associates
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Great Lakes Heart Center Of Alpena
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital K-15
      • Petoskey, Michigan, United States, 49770
        • Michigan Heart And Vascular Specialists
      • Rochester Hills, Michigan, United States, 48307
        • Academic Cardiology Associates
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Tupelo Neurology Clinic, Pa
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cardiovascular Specialists
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Cardiology, PC
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Cardiovascular Associates
    • New York
      • Albany, New York, United States, 12211
        • Capital Cardiology Associates
      • Cortlandt Manor, New York, United States, 10567
        • NYU Hudson Valley Cardiology
      • Mineola, New York, United States, 11501
        • Long Island Heart Associates
      • Saratoga Springs, New York, United States, 12866
        • Dr William Kufs
      • Troy, New York, United States, 12180
        • Capital Cardiology Associates
    • North Carolina
      • Lexington, North Carolina, United States, 27293
        • Terry V. Arnold, Md
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Medical Clinic, Inc
      • Sanford, North Carolina, United States, 27330
        • Sanford Cardiology
    • Ohio
      • Canton, Ohio, United States, 44710
        • Ira R. Friedlander, M.D.
      • Columbus, Ohio, United States, 43210
        • Davis Heart & Lung Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Cardiovascular Physicians
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Medical Group - Clinical Research
      • Hillsboro, Oregon, United States, 97123
        • Hillsboro Cardiology Pc
      • Portland, Oregon, United States, 97205
        • The Portland Clinic, Llp
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Comprehensive Cardiology Consultants
      • Sellersville, Pennsylvania, United States, 18960
        • Grand View - Lehigh Valley Health Services
      • West Chester, Pennsylvania, United States, 19380
        • West Chester Cardiology
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • South Carolina
      • Beaufort, South Carolina, United States, 29906
        • Lowcountry Medical Group, Llc
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greer, South Carolina, United States, 29650
        • Internal Medicine Of Greer
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Knoxville Heart Group
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Sentara York Clinical Research
      • Roanoke, Virginia, United States, 24014
        • Roanoke Heart Institute, Plc
      • Salem, Virginia, United States, 24153
        • Salem Veterans Administration Medical Center
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Walla Walla Clinic
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male and female
  • Age of 50 years or older
  • Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)

  • At least 1 of the following risk factors for stroke:

    • Prior stroke or transient ischemic attack
    • Age of 75 years or older
    • Arterial hypertension on treatment
    • Diabetes mellitus
    • Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
    • Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
    • Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)

  • Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

    • Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
    • Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
  • Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
  • Valvular disease requiring surgery
  • Planned ablation procedure for atrial fibrillation to be performed within 3 months
  • Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)

  • Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

    • Active peptic ulcer disease
    • Platelet count <100,000/mm^3 or hemoglobin <10g/dL
    • Recent stroke (within 10 days)
    • Documented hemorrhagic tendencies or blood dyscrasias
  • Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
  • Severe comorbid condition with life expectancy <1 year
  • Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
  • Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
  • Allergy or adverse reaction to acetylsalicylic acid
  • Required treatment with a thienopyridine (clopidogrel or ticlopidine)
  • Prisoners or participants who are compulsory detained (involuntarily incarcerated)
  • Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
  • Patients who are compulsorily detained for treatment for a psychiatric or physical illness

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apixaban
Drug: Apixaban
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
Other Names:
  • BMS-562247
Active Comparator: Acetylasalicylic acid
Drug: Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event rate=percent of participants with an event divided by the total participants in the arm.
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event rate=percent of participants with an event divided by the total participants in the arm.
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
Time Frame: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Event rate=percent of participants with an event divided by the total participants in the arm.
First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
Time Frame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event rate=percent of participants with an event divided by the total participants in the arm.
Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality
Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 31, 2007

Primary Completion (Actual)

November 30, 2010

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-048

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

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