Trial · NCT00041938
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
NCT00041938, Phase 3, Completed, Columbia University; results first posted 2013-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial. Trials, record NCT00041938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00041938
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
- NCT number
- NCT00041938
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,305 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Heart Disease, Stroke, Ischemic Heart Disease, Myocardial Infarction
- Interventions
- aspirin, Warfarin
- First posted
- 2002-07-22
- Last updated
- 2014-09-05
- Results first posted
- 2013-05-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death | From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years | The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100\*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Secondary | Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. | From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. | The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years. Event rate per 100 patient years = 100\*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient-years for Ischemic Stroke | From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years | Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100\*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient-years for Intracerebral Hemorrhage | From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years | Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100\*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient-years for Death | From date of randomization to date of death component of primary composite outcome, up to 6 years | Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100\*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome | From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years | Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100\*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome. | From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years | Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100\*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome | From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years | Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100\*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome | From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years | Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100\*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
| Other | Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome | From date of randomization to date of death component of secondary composite outcome, up to 6 years | Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100\*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death | From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years | Intent-to-treat analysis: all enrolled patients were analyzed. | events per 100 patient-years | NUMBER |
| SECONDARY | Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. | From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. | Intent-to-treat analysis: all enrolled patients were analyzed. | events per 100 patient-years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient-years for Ischemic Stroke | From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years | Intent-to-treat | rate per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient-years for Intracerebral Hemorrhage | From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years | Intent-to-treat | rate per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient-years for Death | From date of randomization to date of death component of primary composite outcome, up to 6 years | Intent-to-treat | events per 100 patient-years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome | From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years | Intent-to-treat | events per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome. | From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years | Intent-to-treat. | events per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome | From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years | Intent-to-treat. | events per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome | From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years | Intent-to-treat | events per 100 patient years | NUMBER |
| OTHER_PRE_SPECIFIED | Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome | From date of randomization to date of death component of secondary composite outcome, up to 6 years | Intent-to-treat | events per 100 patient years | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death | Aspirin | 7.93 | events per 100 patient-years | ||
| Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death | Warfarin | 7.47 | events per 100 patient-years | ||
| Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. | Aspirin | 12.15 | events per 100 patient-years | ||
| Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. | Warfarin | 12.70 | events per 100 patient-years | ||
| Event Rate Per 100 Patient-years for Ischemic Stroke | Aspirin | 1.36 | rate per 100 patient years | ||
| Event Rate Per 100 Patient-years for Ischemic Stroke | Warfarin | 0.72 | rate per 100 patient years | ||
| Event Rate Per 100 Patient-years for Intracerebral Hemorrhage | Aspirin | 0.05 | rate per 100 patient years | ||
| Event Rate Per 100 Patient-years for Intracerebral Hemorrhage | Warfarin | 0.12 | rate per 100 patient years | ||
| Event Rate Per 100 Patient-years for Death | Aspirin | 6.52 | events per 100 patient-years | ||
| Event Rate Per 100 Patient-years for Death | Warfarin | 6.63 | events per 100 patient-years |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin | 1,163 | |
| Overall Study | STARTED | Warfarin | 1,142 | |
| Overall Study | Completed Follow-up | Aspirin | 761 | |
| Overall Study | Completed Follow-up | Warfarin | 745 | |
| Overall Study | Primary Endpoint | Aspirin | 320 | |
| Overall Study | Primary Endpoint | Warfarin | 302 | |
| Overall Study | Only Vital Status Known | Aspirin | 44 | |
| Overall Study | Only Vital Status Known | Warfarin | 46 | |
| Overall Study | Lost to Follow-up | Aspirin | 18 | |
| Overall Study | Lost to Follow-up | Warfarin | 17 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | All non-serious adverse events | General disorders | Aspirin | 749 | 1,163 | 4,483 |
| other | All non-serious adverse events | General disorders | Warfarin | 799 | 1,142 | 4,895 |
| serious | ALLERGY/IMMUNOLOGY: Other | General disorders | Aspirin | 1 | 1,163 | 1 |
| serious | ALLERGY/IMMUNOLOGY: Other | General disorders | Warfarin | 1 | 1,142 | 1 |
| serious | Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash | General disorders | Aspirin | 4 | 1,163 | 4 |
| serious | Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash | General disorders | Warfarin | 2 | 1,142 | 2 |
| serious | Blood dyscrasia | Blood and lymphatic system disorders | Aspirin | 3 | 1,163 | 3 |
| serious | Blood dyscrasia | Blood and lymphatic system disorders | Warfarin | 4 | 1,142 | 4 |
| serious | BLOOD/BONE MARROW: Other | Blood and lymphatic system disorders | Aspirin | 1 | 1,163 | 1 |
| serious | BLOOD/BONE MARROW: Other | Blood and lymphatic system disorders | Warfarin | 3 | 1,142 | 4 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin | ||
| Total, all-cause mortality | Warfarin | ||
| Total, other adverse events | Aspirin | 749 | 1,163 |
| Total, other adverse events | Warfarin | 799 | 1,142 |
| Total, serious adverse events | Aspirin | 617 | 1,163 |
| Total, serious adverse events | Warfarin | 632 | 1,142 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS039143 | Warfarin vs Aspirin in Reduced Ejection Fraction - STAT | THOMPSON, JOHN L | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2001 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aspirin vs Warfarin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00041938
GET https://conductscience.org/api/trials/v1/NCT00041938/results?page=2