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

Status:	Completed
Conditions:	Atrial Fibrillation, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 95
Updated:	1/13/2019
Start Date:	June 4, 2015
End Date:	November 10, 2018

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:

- 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

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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

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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

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