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

NCT00004564 | Unknown

• 2 other identifiers: NCRR-M01RR00042-1659M01RR000042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Thrombosis

Keywords

Platelet Aggregation Inhibitors; Cerebrovascular accident

Interventions

Clopidogrel DRUG

Atorvastatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

1G323 University Hospital, Box 0048 1500 E Medical Center Drive

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Thrombosis; Stroke

Interventions

Clopidogrel; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Wei C. Lau, M.D.

CONTACT

1-734-936-4280

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 11, 2000
• First Posted: February 14, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)