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

This study is currently recruiting participants.
Verified by National Center for Research Resources (NCRR), December 2003

Sponsored by: National Center for Research Resources (NCRR)
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00004564
  Purpose

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 Intervention
Hypercholesterolemia
Thrombosis
Drug: Clopidogrel
Drug: Atorvastatin

Genetics Home Reference related topics:   hypercholesterolemia   

MedlinePlus related topics:   Blood Thinners    Cholesterol   

Drug Information available for:   Atorvastatin    Atorvastatin calcium    Erythromycin    Erythromycin estolate    Erythromycin ethylsuccinate    Erythromycin Gluceptate    Erythromycin stearate    Clopidogrel    Clopidogrel Bisulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment
  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004564

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

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

Sponsors and Collaborators
  More Information


Study ID Numbers:   NCRR-M01RR00042-1659, M01RR00042
First Received:   February 11, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004564
Health Authority:   United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
Platelet Aggregation Inhibitors  
Cerebrovascular accident  

Study placed in the following topic categories:
Erythromycin stearate
Hyperlipidemias
Metabolic Diseases
Cerebral Infarction
Erythromycin Ethylsuccinate
Stroke
Vascular Diseases
Erythromycin
Thrombosis
Embolism and Thrombosis
Erythromycin Estolate
Embolism
Clopidogrel
Metabolic disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Therapeutic Uses
Hematologic Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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