Recruiting

Atorvastatin with Clopidogrel

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00004564

Conditions

Hypercholesterolemia

Thrombosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Clopidogrel

Atorvastatin

Study Details

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

Study ID

NCT00004564

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Clopidogrel

Atorvastatin

Central Contacts and Locations

Central contacts

Wei C. Lau, M.D.

1-734-936-4280

Locations

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

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

  • Platelet Aggregation Inhibitors
  • Cerebrovascular accident

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.