NCT00465322

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

April 23, 2007

Last Update Submit

April 23, 2007

Conditions

Drug-Interactions

Interventions

fluvastatinDRUG

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Wenaweser P, Eshtehardi P, Abrecht L, Zwahlen M, Schmidlin K, Windecker S, Meier B, Haeberli A, Hess OM. A randomised determination of the Effect of Fluvastatin and Atorvastatin on top of dual antiplatelet treatment on platelet aggregation after implantation of coronary drug-eluting stents. The EFA-Trial. Thromb Haemost. 2010 Sep;104(3):554-62. doi: 10.1160/TH09-11-0765. Epub 2010 Jul 20.

    PMID: 20664903DERIVED

MeSH Terms

Interventions

Fluvastatin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Otto M Hess, Prof.

    Cardiology University Hospital Bern

    PRINCIPAL INVESTIGATOR

  • Peter Wenaweser, MD

    Cardiology University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

CH(1)