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

NCT02415400

Last updated date
Study Location
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, 35243, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Coronary Syndromes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-95 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Acute Coronary SyndromesA 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
NCT02415400
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Scottsdale, Arizona
  6. Tucson, Arizona
  7. Little Rock, Arkansas
  8. Phoenix, Arkansas
  9. Alhambra, California
  10. Culver City, California
  11. Fremont, California
  12. Huntington Beach, California
  13. La Jolla, California
  14. Long Beach, California
  15. Rancho Mirage, California
  16. San Diego, California
  17. Stockton, California
  18. Torrance, California
  19. Aurora, Colorado
  20. Lakewood, Colorado
  21. Norwalk, Connecticut
  22. Wilmington, Delaware
  23. Altamonte Springs, Florida
  24. Bradenton, Florida
  25. Clearwater, Florida
  26. Clearwater, Florida
  27. Daytona Beach, Florida
  28. Fort Lauderdale, Florida
  29. Jacksonville Beach, Florida
  30. Jacksonville, Florida
  31. Jacksonville, Florida
  32. Jupiter, Florida
  33. Lake Mary, Florida
  34. Miami, Florida
  35. Ocala, Florida
  36. Orlando, Florida
  37. Palm Beach Gardens, Florida
  38. Saint Petersburg, Florida
  39. Tampa, Florida
  40. Wellington, Florida
  41. Athens, Georgia
  42. Atlanta, Georgia
  43. Augusta, Georgia
  44. Covington, Georgia
  45. Cumming, Georgia
  46. Tucker, Georgia
  47. Boise, Idaho
  48. Fairview Heights, Illinois
  49. Jerseyville, Illinois
  50. Normal, Illinois
  51. Olympia Fields, Illinois
  52. Bloomington, Indiana
  53. Elkhart, Indiana
  54. Indianapolis, Indiana
  55. Richmond, Indiana
  56. Davenport, Iowa
  57. Iowa City, Iowa
  58. Waterloo, Iowa
  59. Kansas City, Kansas
  60. Wichita, Kansas
  61. Crestview Hills, Kentucky
  62. Louisville, Kentucky
  63. Alexandria, Louisiana
  64. Lake Charles, Louisiana
  65. Minden, Louisiana
  66. Monroe, Louisiana
  67. Natick, Massachusetts
  68. Alpena, Michigan
  69. Ann Arbor, Michigan
  70. Detroit, Michigan
  71. Detroit, Michigan
  72. Lansing, Michigan
  73. Saginaw, Michigan
  74. Minneapolis, Minnesota
  75. Hattiesburg, Mississippi
  76. Jackson, Mississippi
  77. Tupelo, Mississippi
  78. Columbia, Missouri
  79. Columbia, Missouri
  80. Joplin, Missouri
  81. Saint Louis, Missouri
  82. Saint Louis, Missouri
  83. Springfield, Missouri
  84. Billings, Montana
  85. Lincoln, Nebraska
  86. Las Vegas, Nevada
  87. Reno, Nevada
  88. Linden, New Jersey
  89. Albany, New York
  90. Brooklyn, New York
  91. Brooklyn, New York
  92. Buffalo, New York
  93. New York, New York
  94. Poughkeepsie, New York
  95. Asheville, North Carolina
  96. Chapel Hill, North Carolina
  97. Durham, North Carolina
  98. Durham, North Carolina
  99. Lenoir, North Carolina
  100. Lumberton, North Carolina
  101. Wilmington, North Carolina
  102. Canton, Ohio
  103. Columbus, Ohio
  104. Kettering, Ohio
  105. Willoughby, Ohio
  106. Erie, Pennsylvania
  107. Lancaster, Pennsylvania
  108. Newton, Pennsylvania
  109. York, Pennsylvania
  110. Providence, Rhode Island
  111. Columbia, South Carolina
  112. Greenville, South Carolina
  113. North Charleston, South Carolina
  114. Rock Hill, South Carolina
  115. Germantown, Tennessee
  116. Jackson, Tennessee
  117. Knoxville, Tennessee
  118. Knoxville, Tennessee
  119. Oak Ridge, Tennessee
  120. Austin, Texas
  121. Austin, Texas
  122. Dallas, Texas
  123. Fort Sam Houston, Texas
  124. Houston, Texas
  125. Houston, Texas
  126. Houston, Texas
  127. Huntsville, Texas
  128. Huntsville, Texas
  129. Katy, Texas
  130. Lubbock, Texas
  131. Plano, Texas
  132. San Antonio, Texas
  133. San Antonio, Texas
  134. Sealy, Texas
  135. Sugar Land, Texas
  136. Victoria, Texas
  137. Burlington, Vermont
  138. Falls Church, Virginia
  139. Leesburg, Virginia
  140. Richmond, Virginia
  141. Seattle, Washington
  142. Huntington, West Virginia
  143. Wausau, Wisconsin
  144. Buenos Aires, BUA
  145. Bahia Blanca, Buenos Aires
  146. Ciudad Autonoma de Buenos Aires, Buenos Aires
  147. Ciudad Autonoma de Buenos Aires, Buenos Aires
  148. Coronel Suarez, Buenos Aires
  149. Lanus Oeste, Buenos Aires
  150. Mar del Plata, Buenos Aires
  151. Mar Del Plata, Buenos Aires
  152. Quilmes, Buenos Aires
  153. Quilmes, Buenos Aires
  154. Ramos Mejia, Buenos Aires
  155. Ramos Mejia, Buenos Aires
  156. Vicente Lopez, Buenos Aires
  157. Resistencia, Chaco
  158. Ciudad De Cordoba, Cordoba
  159. Villa Allende, Cordoba
  160. Villa Maria, Cordoba
  161. Rosario, Santa FE
  162. Rosario, Santa FE
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  164. Buenos Aires,
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  188. Port Macquarie, New South Wales
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  190. Elizabeth Vale, South Australia
  191. Bedford Park,
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  215. Aparecida de Goiania, Goias
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  220. Uberlandia, Minas Gerais
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  222. Londrina, Parana
  223. Belem, Para
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  225. Recife, Pernambuco
  226. Canoas, RIO Grande DO SUL
  227. Passo Fundo, RIO Grande DO SUL
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  230. Porto Alegre, RIO Grande DO SUL
  231. Porto Alegre, RIO Grande DO SUL
  232. Porto Alegre, RIO Grande DO SUL
  233. Porto Alegre, RIO Grande DO SUL
  234. Blumenau, Santa Catarina
  235. Itajai, Santa Catarina
  236. Campinas, SAO Paulo
  237. Limeira, SAO Paulo
  238. Marilia, SAO Paulo
  239. S?o Paulo, SAO Paulo
  240. S?o Paulo, SAO Paulo
  241. S?o Paulo, SAO Paulo
  242. Santo Andre, SAO Paulo
  243. Sao Jose Do Rio Preto, SAO Paulo
  244. Votuporanga, SAO Paulo
  245. Rio de Janeiro,
  246. Sao Paulo,
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  264. Vidin,
  265. Edmonton, Alberta
  266. Edmonton, Alberta
  267. Edmonton, Alberta
  268. Kelowna, British Columbia
  269. New Westminster, British Columbia
  270. Victoria, British Columbia
  271. Winnepeg, Manitoba
  272. Halifax, Nova Scotia
  273. Cambridge, Ontario
  274. London, Ontario
  275. Oshawa, Ontario
  276. Scarborough, Ontario
  277. Scarborough, Ontario
  278. Sudbury, Ontario
  279. Sudbury, Ontario
  280. Waterloo, Ontario
  281. Green Field Park, Quebec
  282. Laval, Quebec
  283. Longueuil, Quebec
  284. Montreal, Quebec
  285. Sherbrooke, Quebec
  286. St-Georges, Beauce, Quebec
  287. St-Jean-sur-Richelieu, Quebec
  288. St. Jerome, Quebec
  289. Regina, Saskatchewan
  290. Montreal,
  291. Santiago, Metropolitana
  292. Barranquilla,
  293. Barranquilla,
  294. Bogota,
  295. Cali,
  296. Espinal,
  297. Medellin,
  298. Cakovec,
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  300. Karlovac,
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  302. Opatija,
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  310. Zagreb,
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  384. Weiden i.d.OPf.,
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  388. Bekescsaba,
  389. Budapest,
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  395. Keszthely,
  396. Mosonmagyarovar,
  397. Pecs,
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  399. Szeged,
  400. Szekszard,
  401. Szolnok,
  402. Ahmedabad, Gujarat
  403. Bangalore, Karnataka
  404. Amritsar,
  405. Jaipur,,
  406. Lucknow,
  407. Madurai,
  408. Mangalore,
  409. New Delhi,
  410. New Delhi,
  411. Noida,
  412. Shivamogga,
  413. Vadodara,
  414. Vijayawada,
  415. Afula,
  416. Ashkelon,
  417. Hadera,
  418. Haifa,
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  420. Haifa,
  421. Herzliya,
  422. Holon,
  423. Jerusalem,
  424. Ramat-Gan,
  425. Rehovot,
  426. Safed,
  427. Tel Aviv,
  428. Tiberias,
  429. Grosseto,
  430. Busan,
  431. Changwon,
  432. Daegu,
  433. Daegu,
  434. Daejeon,
  435. Gwang Ju,
  436. Incheon,
  437. Seongnam-si,
  438. Seoul,
  439. Seoul,
  440. Seoul,
  441. Seoul,
  442. Torreon, Coahuila
  443. Leon, Guanajuato
  444. Guadalajara, Jalisco
  445. Monterrey, Nuevo LEON
  446. San Juan del Rio, Queretaro
  447. Queretaro, QUE
  448. Culiacan, Sinaloa
  449. Aguascalientes,
  450. Durango,
  451. Puebla,
  452. San Luis Potosi,
  453. San Luis Potosi,
  454. Tlalnepantla De Baz,
  455. Veracruz,
  456. Amsterdam,
  457. Amsterdam,
  458. Arnhem,
  459. Breda,
  460. Ede,
  461. Groningen,
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  465. Rotterdam,
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  468. Bod?,
  469. Oslo,
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  473. Tromso,
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  475. Callao,
  476. Callao,
  477. Cusco,
  478. Lima,
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  481. Bialystok,
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  495. Lubin,
  496. Opole,
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  616. Kirkcaldy, Fife
  617. Stevenage, Hertfordshire
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  619. Northampton, Northamptonshire
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  621. Sheffield, South Yorkshire
  622. Birmingham,
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  624. Dundee,
  625. Wolverhampton,
  626. Christiansted,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: Apixaban
    Other Name: BMS-562247
  • Drug: vitamin K antagonist
  • Drug: Acetylsalicylic acid
    Other Name: Aspirin 81 mg
  • Other: Acetylsalicylic acid placebo
    Other Name: aspirin placebo
Study Arms  ICMJE
  • Active Comparator: Apixaban
    5 mg or 2.5 mg Apixaban tablets orally twice per day
    Intervention: Drug: Apixaban
  • Active Comparator: Vitamin K Antagonist
    VKA tablets orally once daily
    Intervention: Drug: vitamin K antagonist
  • Placebo Comparator: Acetylsalicylic acid film coated tablet
    81 mg Acetylsalicylic acid film coated tablet orally once daily
    Intervention: Drug: Acetylsalicylic acid
  • Placebo Comparator: Placebo matching Acetylsalicylic acid film coated tablet
    Placebo matching Acetylsalicylic acid film coated tablet once daily
    Intervention: Other: Acetylsalicylic acid placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
4614
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
4600
Actual Study Completion Date  ICMJE November 10, 2018
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States,   Virgin Islands (U.S.)
Removed Location Countries Czech Republic,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT02415400
Other Study ID Numbers  ICMJE CV185-316
2014-002004-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Pfizer
  • Duke Clinical Research Institute
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP