We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00465322
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

Brief Summary:
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 or disease Intervention/treatment Phase
Drug-Interactions Drug: fluvastatin Phase 4

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
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 the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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 Posted: April 25, 2007    Key Record Dates
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