Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00465322
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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
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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00465322     History of Changes
Other Study ID Numbers: 1101
Study First Received: April 23, 2007
Last Updated: April 23, 2007
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Clopidogrel
Fluvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hematologic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014