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Effect of Fluvastatin on Top of Clopidogrel and Aspirin in Patients After DES Implantation on Platelet Aggregation (EFA-1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465322
First Posted: April 25, 2007
Last Update Posted: April 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  Purpose
The purpose of the study was to determine the influence of fluvastatin and atorvastatin on platelet aggregation in patients treated with aspirin and plavix after coronary stenting. We hypothezied a positive effect of fluvastatin on platelet aggregation levels.

Condition Intervention Phase
Drug-Interactions Drug: fluvastatin Phase 4

Study Type: Observational
Study Design: Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Effect of Fluvastatin on Top of Clopidogrel and Aspirin in Patients After DES Implantation on Platelet Aggregation

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Estimated Enrollment: 100
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients with stent implantation followed by treatment with aspirin and clopidogrel
  • routinely treated with acetylsalicylic 100 mg/day

Exclusion Criteria:

  • acute coronary syndrome
  • use of a GPIIb/IIIa inhibitor
  • allergy to acetylsalicylic acid, clopidogrel, statins
  • elevated liver enzymes (> 3 x norm value)
  • muscle myopathy
  • active liver disease
  • recent gastrointestinal bleeding (< 3 months)
  • known platelet dysfunction or abnormal platelet count
  • pregnancy
  • indication for treatment with non-steroidal drugs
  • indication for long-term treatment with a drug metabolized by cytochrome p450 3A4 or 2C9
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465322


Locations
Switzerland
Cardiology University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Otto M Hess, Prof. Cardiology University Hospital Bern
Principal Investigator: Peter Wenaweser, MD Cardiology University Hospital Bern
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00465322     History of Changes
Other Study ID Numbers: 1101
First Submitted: April 23, 2007
First Posted: April 25, 2007
Last Update Posted: April 25, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Aspirin
Clopidogrel
Fluvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors