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
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.
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.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arkansas 85015, United States
Lumberton, North Carolina 28358, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires 1406, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1431, Argentina
S?o Paulo, São Paulo 01327-010, Brazil
S?o Paulo, São Paulo 04004-030, Brazil
S?o Paulo, São Paulo 08270-070, Brazil
Veliko Tarnova, 5000, Bulgaria
Winnepeg, Manitoba R2H 2A6, Canada
Green Field Park, Quebec J4V 2H1, Canada
Frederiksburg, 2000, Denmark
Holb?k, DK-4300, Denmark
Bad Friedrichshall, 74177, Germany
Karlsbad, 76307, Germany
Weiden i.d.OPf., 92637, Germany
Bod?, NO-8005, Norway
Guimar?es, 4835-044, Portugal
Belgarde, 11000, Serbia
Zhaporizhzhya, 69000, Ukraine