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SPAF-III TRIAL |
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|---|---|
| Problem | Atrial fibrillation |
| Format | Multi-center RCT |
| Treatment | Warfarin (INR 1.2-1.5) + Aspirin 325mg |
| Control | Warfarin (INR 2-3) |
| Population | 1044 patients |
| Inclusion criteria | Aged > 18 AF documented in the 6 month preceding the study One or more high risk features -Impared left ventricular function manifest by recent(100 days) congestive heart failure or left ventricular fractional shortening < 25% -Previous thromboembolism(systemic stroke ,TIA,systemic embolism) more than 30 days prior to entry -Systolic blood pressure of more than 160 mmHg at study enrolment -Women >75 y. |
| Exclusion criteria | Prosthetic heart valves Mitral stenosis Prior requirement for anticoagulation Contra-indications to aspirin or warfarin Regular use of NSAIDs Patients who had taken part in previous SPAF studies or similar clinical trials. |
| Follow-up | Mean 1.1 years |
| Primary endpoint | Ischemic stroke and systemic embolism as measured during monthly telephone interview, clinic follow-up every 3 months, and yearly standard symptom questionnaire |
| Secondary endpoint(s) | Transient ischemic attack, intracranial hemorrhage, disabling or fatal stroke. |
| Details | - |
| Brief summary: | INR monitoring necessary for warfarin |
| PAPER: Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. | |
|---|---|
| Date | 7 Sep 1996 |
| Journal | Lancet. 1996 Sep 7;348(9028):633-8. |
| Information | Low-intensity fixed-dose warfarin + aspirin vs. INR 2-3 -7.9%/yr primary event (stroke and systemic embolism) vs. 1.9% -Increased risk of disabling stroke -Increased risk of primary event or vascular death -Similar rates of major bleeding |
| PAPER: Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. | |
|---|---|
| Date | 19 Oct 2004 |
| Journal | Circulation. 2004 Oct 19;110(16):2287-92. |
| Information | 2580 patients - pooled data from SPAF-III, AFASAK-1, AFASAK-2, and others CHADS2 scheme identified primary prevention patients at high risk (>5.3/100pt yrs) -Low-risk patients had 0.5 - 1.4 strokes/100 pr yrs Other schemes predicted high risk patients as 3.0-4.2/100pt yrs |