The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A

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ClinicalTrials.gov Identifier: NCT00004564

Recruitment Status : Unknown

Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Recruiting

First Posted : February 14, 2000

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

National Center for Research Resources (NCRR)

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia Thrombosis	Drug: Clopidogrel Drug: Atorvastatin	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know

Drug Information available for: Clopidogrel Clopidogrel bisulfate Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004564

Contacts

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Contact: Wei C. Lau, M.D.	1-734-936-4280

Locations

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United States, Michigan
1G323 University Hospital, Box 0048 1500 E Medical Center Drive	Recruiting
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

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ClinicalTrials.gov Identifier:	NCT00004564 History of Changes
Other Study ID Numbers:	NCRR-M01RR00042-1659 M01RR000042 ( U.S. NIH Grant/Contract )
First Posted:	February 14, 2000 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	December 2003

Keywords provided by National Center for Research Resources (NCRR):


Platelet Aggregation Inhibitors Cerebrovascular accident

Additional relevant MeSH terms:

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Thrombosis Hypercholesterolemia Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Clopidogrel Atorvastatin Anticholesteremic Agents Hypolipidemic Agents	Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Physiological Effects of Drugs

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