WARCEF
Protocol Number: NA
Therapeutic Area: Cardiology
Summary:
Patients with low left ventricular ejection fraction will be followed for 2-6 years to determine if warfarin (with target INR of 2.75 + 0.25) is superior to aspirin (325 mg per day) for prevention of ischemic stroke, intracerebral hemorrhage, or death. WARCEF is an intent-to-treat trial, so all patients, even those who discontinue study medication, are followed until they develop a primary endpoint or the trial ends.
Inclusion Criteria:
- EF <35%
- Currently on warfarin or aspirin
- Modified Rankin Score < 4
- Taking ACE inhibitors. If intolerant of ACE inhibitors patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
Exclusion Criteria:
- Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
- A contraindication to the use of either warfarin or aspirin.
- Hospitalization for new diagnosis of onset of CHF within one month of randomization or carotid endarterectomy or pacemaker insertion within one month prior to randomization.
*Additional Eligibility Criteria Exist*
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: asilva@mercymiami.org