Status:
COMPLETED
Biological Efficacy of Clopidogrel After Implantation of Drug-eluting Stents (SPACE)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Sanofi
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is recommended that all pat...
Detailed Description
The risk of thrombotic complications after implantation of drug-eluting stents (DES) in coronary arteries may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00298428
Start Date
May 1 2006
End Date
December 1 2008
Last Update
September 26 2011
Active Locations (2)
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1
Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris
Paris, France, 75018
2
Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris
Paris, France, 75018