The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A
Primary Purpose
Hypercholesterolemia, Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clopidogrel
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Platelet Aggregation Inhibitors, Cerebrovascular accident
Eligibility 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
Sites / Locations
- 1G323 University Hospital, Box 0048 1500 E Medical Center DriveRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004564
First Posted
February 11, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00004564
Brief Title
The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Thrombosis
Keywords
Platelet Aggregation Inhibitors, Cerebrovascular accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei C. Lau, M.D.
Phone
1-734-936-4280
Facility Information:
Facility Name
1G323 University Hospital, Box 0048 1500 E Medical Center Drive
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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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