Investigation of the Athero-Protective Effects of Clopidogrel

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels. The investigators will give half of the patients clopidogrel and the other half a sugar pill, placebo, and check the levels of these markers and helpful cells in each group. At the same time the investigators will check how well these patient's blood vessels work using ultrasound imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's blood vessels are. After 6 weeks of drug therapy, the patients will switch to the other drug and these same tests will be performed after an additional 6 weeks of therapy. The drug taken by the patient will not be known to the patient or the researchers. The patients will continue on their prescribed medical therapy during the duration of the 12 week study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Male or females without child bearing potential aged 21-80 years

• Known coronary artery disease by angiogram or documented myocardial infarction.

• Able to provide written informed consent

Exclusion Criteria:

• Treated with clopidogrel or ticlodipine in the previous 3 months

• Age < 21 or >80 years

• Premenopausal females with potential for pregnancy

• Allergy to clopidogrel or aspirin

• Initiation or change in dose of any concomitant medical therapy within 2 months before the study

• Uncontrolled hypertension with BP>180 mmHg systolic and >120 mmHg diastolic

• Treated with coumadin therapy

• Intolerance or allergy to statins

• Acute infection in previous 4 weeks

• History of substance abuse

• Uninterpretable PAT test

• Current neoplasm

• Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X normal)

• Acute coronary syndrome, heart failure, CVA, coronary intervention within 3 months

• Known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.

• Inability to give informed consent

• Inability to return to Emory for follow-up