Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007683
Status:
COMPLETED
Last Update Posted:
2011-06-16
First Post:
2000-12-29
Brief Title:
Warfarin and Antiplatelet Therapy in Chronic Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure WATCH
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg prevention of arterial emboli or reduction in vascular events
Detailed Description:
Primary Hypothesis The hypothesis to be tested is whether aspirin warfarin and clopidogrel are equally effective in the treatment of patients with symptomatic CHF and reduced ejection fraction
Secondary Hypothesis If one therapy proves to be superior with regard to outcomes what is the cost of this benefit Can subsets of patients be identified who benefit more from a specific approach to antithrombotic therapy
Intervention The three treatment regimens are
1 Open-label Warfarin titrated to an INR of 25-30
2 Double blind aspirin 162 mg once daily
3 Double blind clopidogrel 75 mg once daily
Primary Outcomes Any death all causes non-fatal stroke non-fatal MI
Study Abstract 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 eg prevention of arterial emboli or reduction in vascular events
The original target sample size was 4500 over a 3 year enrollment period with a 2 year follow-up This sample size yielded 90 power to detect a relative difference of 20 between treatment groups The sample size was later amended to 1500 over a 30 month enrollment period with a 12 month follow-up The reduced sample size yielded 85 to detect a between treatment difference of 30 This change became effective in March 2002
This clinical trial enrolled 1587 patients in 142 medical centers VA and non-VA centers in the US and medical centers in the United Kingdom and Canada Patients were randomly and equally allocated to the 3 treatments warfarin administered open-label aspirin and clopidogrel the latter two administered double-blind The study was conducted over a 35 year period with a 25 year enrollment phase
Patients with NYHA class II III or IV and left ventricular ejection fractions less than or equal to 35 on an ACE inhibitor unless not tolerated and a diuretic were entered The primary end point is the composite of death from any cause non-fatal MI and non-fatal stroke All-cause mortality is the secondary end point
The WATCH design paper has been published in the Journal of Cardiac Failure Preliminary results were presented at the meeting of the American College of Cardiology in New Orleans on March 9 2004 There were no significant differences between the treatment groups for the primary endpoints The paper with final results is being prepared
Secondary Hypothesis If one therapy proves to be superior with regard to outcomes what is the cost of this benefit Can subsets of patients be identified who benefit more from a specific approach to antithrombotic therapy
Intervention The three treatment regimens are
1 Open-label Warfarin titrated to an INR of 25-30
2 Double blind aspirin 162 mg once daily
3 Double blind clopidogrel 75 mg once daily
Primary Outcomes Any death all causes non-fatal stroke non-fatal MI
Study Abstract 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 eg prevention of arterial emboli or reduction in vascular events
The original target sample size was 4500 over a 3 year enrollment period with a 2 year follow-up This sample size yielded 90 power to detect a relative difference of 20 between treatment groups The sample size was later amended to 1500 over a 30 month enrollment period with a 12 month follow-up The reduced sample size yielded 85 to detect a between treatment difference of 30 This change became effective in March 2002
This clinical trial enrolled 1587 patients in 142 medical centers VA and non-VA centers in the US and medical centers in the United Kingdom and Canada Patients were randomly and equally allocated to the 3 treatments warfarin administered open-label aspirin and clopidogrel the latter two administered double-blind The study was conducted over a 35 year period with a 25 year enrollment phase
Patients with NYHA class II III or IV and left ventricular ejection fractions less than or equal to 35 on an ACE inhibitor unless not tolerated and a diuretic were entered The primary end point is the composite of death from any cause non-fatal MI and non-fatal stroke All-cause mortality is the secondary end point
The WATCH design paper has been published in the Journal of Cardiac Failure Preliminary results were presented at the meeting of the American College of Cardiology in New Orleans on March 9 2004 There were no significant differences between the treatment groups for the primary endpoints The paper with final results is being prepared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None