Augustus

STUDY IDENTIFIER:

Augustus

CONDITION:

Acute Coronary Syndromes

CONTACT INFO:

Christine Majeski   |   christine.majeski@allina.com   |   612-863-3546

DESCRIPTION:

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.

CRITERIA LIST/ QUALIFICATIONS:

  • 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

  • Exclusion Criteria: Conditions other than atrial fibrillation that require chronic anticoagulation (e.g. prosthetic mechanical heart valve).

 

INVESTIGATORS:

Nedaa Skeik, MD; Emmanouil Brilakis, MD

SPONSORS:

Bristol-Myers Squibb

STATUS:

Hasn't started

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