The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A
Information source: National Center for Research Resources (NCRR)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Thrombosis
Intervention: Clopidogrel (Drug); Atorvastatin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: National Center for Research Resources (NCRR) Overall contact:
Wei C. Lau, M.D., Phone: 1-734-936-4280
Summary
The objective of this study is to determine if the action of the drug called clopidogrel,
that you will start taking, will be decreased by another drug called atorvastatin, that you
will also start taking. Clopidogrel is an oral antiplatelet agent that has been shown to
prevent strokes and heart attacks. Atorvastatin is a cholesterol lowering agent.
Twenty adults 18-75 years of age requiring cholesterol-lowering agent and antiplatelet agent
therapy will be recruited for this study during their cardiology clinic visitation. In one
group, antiplatelet agent (clopidogrel) regimen will be administered first, then followed by
cholesterol-lowering medication (atorvastatin). In the second group, atorvastatin will be
administered first, followed by clopidogrel.
A new test called the erythromycin breath test will be administered to you three times
during the study to measure how your liver will metabolize these drugs. Blood samples will
also be obtained to assess platelet function. The criteria for exclusion are patient
refusal or inability to give written consent, patients with allergic reaction to
erythromycin, patients with known bleeding problems, liver disease, significant lung disease
kidney disease and pregnancy. Patients with psychiatric impairment and documented history
of substance abuse will also be excluded from the study.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females age 18-75 years of age without bias in racial and ethnic
background, undergoing percutaneous coronary intervention requiring antiplatelet
therapy: 1. Patients presented to cardiology clinic requiring cholesterol lowering
agent 2. Patients presented to cardiology clinic requiring antiplatelet agent.
Exclusion Criteria:
- Refusal or inability to give written consent
- Allergic reaction to erythromycin
- Have known bleeding problems, liver disease, significant lung disease kidney disease
- Pregnancy
- Psychiatric impairment and documented history of substance abuse
Locations and Contacts
Wei C. Lau, M.D., Phone: 1-734-936-4280
1G323 University Hospital, Box 0048 1500 E Medical Center Drive, Ann Arbor, Michigan 48109, United States; Recruiting
Additional Information
Last updated: June 23, 2005
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