Clopidogrel Pharmacogenetics (PGX) Bench to Bedside

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Food and Drug Administration (FDA); National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI); National Institute of General Medical Sciences (NIGMS)
• Treatments: Clopidogrel; Omeprazole; Ticlopidine

Criteria

Inclusion Criteria:

• Amish men or women between 20 and 70 years of age who participated in PAPI

Exclusion Criteria:

• Severe hypertension (bp > 160/95 mm Hg)

• Co-existing malignancy

• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2 times normal

• Creatinine >2.0

• Hct < 32 or Hct > 50

• Thyroid Stimulating Hormone (TSH) < 0.40 or >5.50

• History of bleeding disorder or gastrointestinal bleeding

• History of unstable angina, myocardial infarction (MI), angioplasty, coronary artery bypass surgery

• History of atrial fibrillation, stroke or transient ischemic attacks or deep vein thrombosis

• Type 2 diabetes

• Thrombocytosis (platelet count > 500,000) or thrombocytopenia (platelet count < 150,000)

• Surgery within six months

• Clopidogrel allergy

• Pregnant women

• Currently breast feeding

• Omeprazole allergy

• Prospective participants taking medications that would affect the outcome(s) to be measured and who cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation, or who are taking vitamins and/or other supplements and who are unwilling to discontinue their use for at least 1 week prior to study