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

Completed · Phase 4 · Has a placebo group

Conditions studied: Acute Coronary Syndromes

In brief

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.

Key facts

Study ID: NCT02415400
Run by: Bristol-Myers Squibb
People needed: 4614
Starts: 2015-06-04
Expected to finish: 2018-11-10
Last updated by the study team: 2020-06-11

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Arizona Heart Rhythm Center — Phoenix, Arizona, United States
Local Institution — Phoenix, Arizona, United States
Scottsdale Osborn Medical Center — Scottsdale, Arizona, United States
Southern Arizona VA Health Care System — Tucson, Arizona, United States
Local Institution — Little Rock, Arkansas, United States
Local Institution — Phoenix, Arkansas, United States
Comprehensive Cardiovascular Specialists — Alhambra, California, United States
Local Institution — Culver City, California, United States
Washington Township Medical Foundation — Fremont, California, United States
California Heart Specialist, Inc. — Huntington Beach, California, United States
Foundation For Cardiovascular Medicine — La Jolla, California, United States
Local Institution — Long Beach, California, United States
Local Institution — Rancho Mirage, California, United States
Local Institution — San Diego, California, United States
Manshadi Heart Institute — Stockton, California, United States
Local Institution — Torrance, California, United States
University Of Colorado — Aurora, Colorado, United States
Colorado Heart and Vascular — Lakewood, Colorado, United States
Local Institution — Norwalk, Connecticut, United States
Local Institution — Wilmington, Delaware, United States
Orlando Heart Specialists — Altamonte Springs, Florida, United States
Local Institution — Bradenton, Florida, United States
Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States
Cardiovascular Associates of the Southeast, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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