Biological Efficacy of Clopidogrel After Implantation of Drug-eluting Stents (SPACE) (SPACE)
Coronary Artery Disease, Atherosclerosis, Diabetes Mellitus
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring stent, percutaneous coronary intervention, platelet aggregation, clopidogrel, shear, metabolic syndrome
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Documented myocardial ischaemia (stable angina with positive stress ECG or stress myocardial scintigraphy, silent ischemia with positive stress ECG or stress myocardial scintigraphy, non-ST elevation acute coronary syndrome) Treatment with at least 100 mg/day of aspirin for ≥ 6 hours before percutaneous coronary intervention 600 mg clopidogrel loading-dose given ≥ 6 hours and < 24 hours before coronary angiography Presence of one or several stenosis in native coronary arteries requiring percutaneous coronary intervention and implantation of one or several drug-eluting stents Exclusion Criteria: ST-elevation acute coronary syndrome Pregnancy or breast feeding Severe disease with life expectancy lower than 1 year High bleeding risk (blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding) Intolerance or contraindication to aspirin or clopidogrel Current treatment (or stopped < 10 days) with vitamin K antagonist Current treatment (or stopped < 10 days) with clopidogrel (except for the clopidogrel loading-dose given prior to percutaneous coronary intervention), ticlopidine, dipyridamole, non-steroidal antiinflammatory agent, GPIIB-IIIA blocker One-year follow-up impossible Refusal to sign the information and consent form
Sites / Locations
- Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris
- Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris
Arms of the Study
Arm 1
Other
SPACE group