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ARISTOTLE TRIAL |
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|---|---|
| Problem | Atrial fibrilation |
| Format | Double-blinded double-dummy multi-center RCT |
| Treatment | Apixaban |
| Control | Warfarin |
| Population | 18,201 patients |
| 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% -Diabetes mellitus -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) |
| Details | . |
| 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 -Less bleeding -Lower mortality |