Phase 3
Completed N=2,305
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
Heart Disease · Stroke · Ischemic Heart Disease · Myocardial Infarction
Source: ClinicalTrials.gov NCT00041938 ↗
Enrolled (actual)
2,305
Serious AEs
54.2%
Results posted
May 2013
Primary outcomePrimary: Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death — 7.93; 7.47 events per 100 patient-years — p=0.40
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death |
7.93; 7.47 | 0.40 |
| SECONDARY Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. |
12.15; 12.70 | 0.33 |
Eligibility Criteria
Inclusion Criteria
- Cardiac EF 1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
- Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
- Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
- Comorbid conditions that may limit survival to less than five years.
- Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
- Enrollment in another study that would conflict with WARCEF.
- Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
- Person under 18 years of age.
Data sourced from ClinicalTrials.gov (NCT00041938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.