Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00041938 |
Recruitment Status :
Completed
First Posted : July 22, 2002
Results First Posted : May 14, 2013
Last Update Posted : September 5, 2014
|
Sponsor:
Columbia University
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Shunichi Homma, Columbia University
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Conditions |
Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction |
Interventions |
Drug: aspirin Drug: Warfarin |
Enrollment | 2305 |
Participant Flow
Recruitment Details | Recruited 2305 patients at 176 sites in 11 countries, between 10/1/2002 and 1/31/2010. |
Pre-assignment Details | Intent-to-treat trial - all randomized patients followed and analyzed. |
Arm/Group Title | Aspirin | Warfarin |
---|---|---|
![]() |
Aspirin : 325 mg per day | Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75 |
Period Title: Overall Study | ||
Started | 1163 | 1142 |
Completed Follow-up | 761 | 745 |
Primary Endpoint | 320 | 302 |
Only Vital Status Known | 44 | 46 |
Lost to Follow-up | 18 | 17 |
Withdrew Consent | 20 | 14 |
Completed | 1125 | 1111 |
Not Completed | 38 | 31 |
Baseline Characteristics
Arm/Group Title | Aspirin | Warfarin | Total | |
---|---|---|---|---|
![]() |
Aspirin : 325 mg per day | Warfarin : INR 2.5-3.0; target INR 2.75 | Total of all reporting groups | |
Overall Number of Baseline Participants | 1163 | 1142 | 2305 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1163 participants | 1142 participants | 2305 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
732 62.9%
|
706 61.8%
|
1438 62.4%
|
|
>=65 years |
431 37.1%
|
436 38.2%
|
867 37.6%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 1163 participants | 1142 participants | 2305 participants | |
61 (11.1) | 61 (11.6) | 61 (11.3) | ||
Sex/Gender, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1163 participants | 1142 participants | 2305 participants |
Male | 936 | 904 | 1840 | |
Female | 224 | 236 | 460 | |
Unknown | 3 | 2 | 5 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 1163 participants | 1142 participants | 2305 participants |
North America | 546 | 573 | 1119 | |
Europe | 567 | 527 | 1094 | |
Argentina | 50 | 42 | 92 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. J.L.P. (Seamus) Thompson |
Organization: | Columbia University |
Phone: | 212-342-1252 |
EMail: | jlt12@columbia.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shunichi Homma, Columbia University |
ClinicalTrials.gov Identifier: | NCT00041938 |
Other Study ID Numbers: |
AAAC1093 U01NS039143-01 ( U.S. NIH Grant/Contract ) R01NS39154 CRC |
First Submitted: | July 19, 2002 |
First Posted: | July 22, 2002 |
Results First Submitted: | January 3, 2013 |
Results First Posted: | May 14, 2013 |
Last Update Posted: | September 5, 2014 |