Condition category
Circulatory System
Date applied
24/01/2006
Date assigned
27/01/2006
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof François Mach

ORCID ID

Contact details

Geneva University Hospital
Cardiology Division
24 Micheli-du-Crest
Geneva
1211
Switzerland
+41 (0)22 382 7234
francois.mach@medecine.unige.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

150 mg/day maintenance dose will increase the biological effect of clopidogrel in clopidogrel low responders

Ethics approval

This protocol has been approved by the ethics committee of the internal medicine department in November 2005

Study design

Open labelled clinical study with patients admitted for coronary angioplasty

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular outpatients

Intervention

After a loading dose of clopidogrel (600 mg), patients will take a standard dose of clopidogrel 75 mg once a day for 15 days.


At day 15, adenosine diphosphate (ADP) induced platelet aggregation and measurement of phosphorylated vasodilator-stimulated phosphoprotein (VASP-P) by a flow cytometric technique will be performed. If patients are clopidogrel resistant, they will receive 150 mg (2x75) once a day during the next 15 days. ADP-induced platelet aggregation and measurement of VASP-P will be performed at day 30.

Intervention type

Drug

Phase

Not Specified

Drug names

Clopidogrel

Primary outcome measures

Biological effect of clopidogrel

Secondary outcome measures

Genetic association study

Overall trial start date

01/12/2005

Overall trial end date

30/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Cardiovascular outpatients on 75 mg/day clopidogrel

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150

Participant exclusion criteria

Anticoagulation

Recruitment start date

01/12/2005

Recruitment end date

30/12/2006

Locations

Countries of recruitment

Switzerland

Trial participating centre

Geneva University Hospital
Geneva
1211
Switzerland

Sponsor information

Organisation

Geneva University Hospital (Switzerland)

Sponsor details

Cardiology Division
24 Micheli-du-Crest
Geneva
1211
Switzerland
+41 (0)22 382 7234
marjorie.burkhard@hcuge.ch

Sponsor type

Hospital/treatment centre

Website

http://www.cardiology-geneva.ch

Funders

Funder type

University/education

Funder name

University of Geneva Cardiology Foundation (GECOR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Geneva University Hospital Internal Medicine Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes