Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041938
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2002-07-19
Brief Title:
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction WARCEF Trial
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction WARCEF Trial
Status:
COMPLETED
Status Verified Date:
2014-08
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:
WARCEF
Brief Summary:
The purpose of this study is to determine which of two treatments Warfarin or aspirin is better for preventing death and stroke in patients with poor heart function
We are now transitioning into the sub-analysis part of the WARCEF patient data
The study has recently completed data analysis for its Primary Aim All randomized patients have completed their follow up All study related procedure as per the protocol has been completed We are now in the extension phase of the study to obtain more patient data to address further aims of the study No new procedures are performed and data already in place at the sites will be collected EKG and echocardiograms
The aims for this study extension are
To assess progression of cardiac dysfunction over time among heart failure patients
To correlate prognosis with cardiac dysfunction
We are now transitioning into the sub-analysis part of the WARCEF patient data
The study has recently completed data analysis for its Primary Aim All randomized patients have completed their follow up All study related procedure as per the protocol has been completed We are now in the extension phase of the study to obtain more patient data to address further aims of the study No new procedures are performed and data already in place at the sites will be collected EKG and echocardiograms
The aims for this study extension are
To assess progression of cardiac dysfunction over time among heart failure patients
To correlate prognosis with cardiac dysfunction
Detailed Description:
Warfarin has proven effective in patients with ischemic heart disease especially in the reduction of stroke death and re-infarction following myocardial infarction and in the reduction of stroke in atrial fibrillation Warfarin is the most promising unstudied intervention in patients with cardiac failure This randomized double-blind multi-center study will define optimal antithrombotic therapy for patients with cardiac heart failure and patients with low ejection fraction EF EF is the proportion of left ventricular volume emptied during systole It reliably measures left ventricular systolic function
With the rapidly increasing numbers of elderly patients with heart failure this study has important public health implications The study will determine which of two commonly used treatments Warfarin an anticoagulant or aspirin a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction
With the rapidly increasing numbers of elderly patients with heart failure this study has important public health implications The study will determine which of two commonly used treatments Warfarin an anticoagulant or aspirin a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRC | US NIH GrantContract | None | httpsreporternihgovquickSearchU01NS039143-01 |
| U01NS039143-01 | NIH | None | None |
| R01NS39154 | None | None | None |