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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Wei C. Lau, M.D. | 1-734-936-4280 |
| United States, Michigan | |
| 1G323 University Hospital, Box 0048 1500 E Medical Center Drive | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
More Information
| Study ID Numbers: | NCRR-M01RR00042-1659, M01RR00042 |
| Study First Received: | February 11, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004564 History of Changes |
| Health Authority: | United States: Federal Government |
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Platelet Aggregation Inhibitors Cerebrovascular accident |
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Antimetabolites Erythromycin stearate Hyperlipidemias Metabolic Diseases Cerebral Infarction Erythromycin Ethylsuccinate Antilipemic Agents Stroke Vascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Erythromycin |
Thrombosis Embolism and Thrombosis Erythromycin Estolate Embolism Clopidogrel Platelet Aggregation Inhibitors Hypercholesterolemia Metabolic Disorder Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Hematologic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
Thrombosis Embolism and Thrombosis Therapeutic Uses Clopidogrel Cardiovascular Diseases Platelet Aggregation Inhibitors Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |