Protocols

Multidisciplinary Research Building
Protocols - WARCEF-Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction
| Title of Study: |
WARCEF-Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction |
| Contact Person: |
Margaret McBride, Research Coordinator
(404) 756-8818
(primary)
None (alternate)
mmcbride@msm.edu
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| Goal or Purpose: |
To determine which two blood thinning drugs, warafin or aspirin, are more successful at preventing a reoccurrence in heart disease in patients with heart failure.
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| Inclusion Criteria: |
-Diagnosed with heart failure by physician
-Cardiac Ejection Fraction < 35%
-Modified Rankin Score <4
-Patient must be taking ACE inhibitors. If patient is intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
-Patient is able to follow outpatient protocol (requiring monthly blood test and clinic visits every 4 months and the duration of the study) and is available by telephone.
-Patient understands the purpose and the requirements of the study, can make him/herself understood and has given informed consent.
-Patients with recent stroke or TIA within 12 months will be eligible to be included in the recent stroke subgroup |
| Exclusion Criteria: |
-The presence of any of the following cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
-Eisenmenger’s syndrome
-Decompensated heart failure
-Cardiac surgery, angioplasty, or MI within the past 3 months
-A contraindication to the use of either warafin or aspirin
-Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
-Dementia or psychiatric problem that prevents the patient from knowing a
-Comorbid conditions that may limit survival to less than five years
-Pregnancy or female of childbearing potential not sterilized or is not using a medically accepted form of contraception
-Enrollment in another study that would conflict with the current study
-Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy
-Persons under 18 yrs of age
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| Duration: |
WARCEF is a five (5) year study. Patients will visit every three (3) days for the first two weeks. Then patients will visit once a month or as needed. |
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Clinical Research Center at Morehouse School of Medicine
720 Westview Drive SW, Atlanta, Georgia 30310 - 404 756 5787