|Format||Double-blinded double-dummy multi-center RCT|
|Inclusion criteria||Atrial fibrillation or flutter at enrollment or two or more episodes of atrial fibrillation or flutter, as documented by electrocardiography, at least 2 weeks apart in the 12 months before enrollment.
In addition, at least one of the following risk factors for stroke was required:
-Age of at least 75 years
-Previous stroke, transient ischemic attack, or systemic embolism
-Symptomatic heart failure within the previous 3 months or left ventricular ejection fraction of no more than 40%
-Hypertension requiring pharmacologic treatment.
|Exclusion criteria||Atrial fibrillation due to a reversible cause
Moderate or severe mitral stenosis
Conditions other than atrial fibrillation that required anticoagulation (e.g., a prosthetic heart valve)
Stroke within the previous 7 days
Need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel
Severe renal insufficiency (serum creatinine level of >2.5 mg per deciliter [221 Î_mol per liter] or calculated creatinine clearance of <25 ml per minute).
|Follow-up||Median 1.8 years|
|Primary endpoint||Ischemic or hemorrhagic stroke or systemic embolism|
|Secondary endpoint(s)||Death from any cause
Primary safety outcome: major bleeding, according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH)
|Brief summary:||Apixiban improved mortality, bleeding and stroke rates|
|PAPER: Apixaban versus warfarin in patients with atrial fibrillation.|
|Date||15 Sep 2011|
|Journal||N Engl J Med. 2011 Sep 15;365(11):981-92.|
|Information||Apixaban (vs Warfarin)
-Lower rates of stroke or systemic embolism