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Protocols

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

                                   
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.  

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

                                   
   
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