| ISRCTN | ISRCTN14751416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14751416 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/01/2006
- Registration date
- 27/01/2006
- Last edited
- 14/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof François Mach
Scientific
Scientific
Geneva University Hospital
Cardiology Division
24 Micheli-du-Crest
Geneva
1211
Switzerland
| Phone | +41 (0)22 382 7234 |
|---|---|
| francois.mach@medecine.unige.ch |
Study information
| Study design | Open labelled clinical study with patients admitted for coronary angioplasty |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 150 mg/day maintenance dose will increase the biological effect of clopidogrel in clopidogrel low responders |
| Ethics approval(s) | This protocol has been approved by the ethics committee of the internal medicine department in November 2005 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clopidogrel |
| Primary outcome measure | Biological effect of clopidogrel |
| Secondary outcome measures | Genetic association study |
| Overall study start date | 01/12/2005 |
| Completion date | 30/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 150 |
| Key inclusion criteria | Cardiovascular outpatients on 75 mg/day clopidogrel |
| Key exclusion criteria | Anticoagulation |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 30/12/2006 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Geneva University Hospital
Geneva
1211
Switzerland
1211
Switzerland
Sponsor information
Geneva University Hospital (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Cardiology Division
24 Micheli-du-Crest
Geneva
1211
Switzerland
| Phone | +41 (0)22 382 7234 |
|---|---|
| marjorie.burkhard@hcuge.ch | |
| Website | http://www.cardiology-geneva.ch |
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
University/education
University of Geneva Cardiology Foundation (GECOR)
No information available
Geneva University Hospital Internal Medicine Department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
