Last updated on August 2018

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02415400

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Site 0627

Local Institution
Rijeka, Croatia
0.81miles

Site 0672

Local Institution
Opatija, Croatia
6.8miles