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Warfarin and Antiplatelet Therapy in Chronic Heart Failure

NCT00007683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1587

Last updated 2011-06-16

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Warfarin titrated to an INR of 2.5-3.0

anticoagulation (administered without blinding) titrated to a target INR of 2.5 to 3.0, monitored by measurements at 6 week intervals after initial titration and stabilization.

DRUG

Aspirin

an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.

DRUG

Clopidogrel 75

(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

Sponsors & Collaborators

Principal Investigators

  • Barry M. Massie, MD · VA Medical Center, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-31
Primary Completion
2003-07-31
Completion
2004-12-31

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007683 on ClinicalTrials.gov