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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004564
First received: February 11, 2000
Last updated: June 23, 2005
Last verified: December 2003
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Hypercholesterolemia
Thrombosis
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Atorvastatin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 20, 2014