Effect of Fluvastatin on Top of Clopidogrel and Aspirin in Patients After DES Implantation on Platelet Aggregation - Full Text View

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

This study has been completed.

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00465322

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 IV

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Fluvastatin

U.S. FDA Resources

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

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

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

Study ID Numbers:	1101
Study First Received:	April 23, 2007
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00465322
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Aspirin
Clopidogrel
Fluvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Therapeutic Uses
Hematologic Agents

Enzyme Inhibitors
Platelet Aggregation Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009