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CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).
Details
| Lead sponsor | US Department of Veterans Affairs |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1587 |
| Start date | 1998-10 |
| Completion | 2004-12 |
Conditions
- Heart Failure
Interventions
- Warfarin titrated to an INR of 2.5-3.0
- Aspirin
- Clopidogrel 75
Primary outcomes
- acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke — 30 months intake; 12-42 months follow-up
The primary safety end point was major bleeding episodes, defined as bleeding episodes leading to death or disability (including loss of neurological or special senses function), requiring surgical intervention, or associated with an acute decline of hemoglobin 2gm/dl or transfusion of \>1 U packed red cells or whole blood.
Countries
United States, Canada, United Kingdom