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
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