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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Sanofi-Aventis |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00298428 |
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 patients take an association of aspirin and clopidogrel for several months after DES implantation to reduce this risk. However, the biological efficacy of current antiplatelet therapies has not been studied prospectively and specifically in DM or MS patients.
Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600 mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo shear-induced platelet aggregation (SIPA), along with other assays measuring platelet activation and aggregation, in patients with DM, MS, or no DM/MS.
Patients with stable coronary artery disease and successful DES implantation in native coronary arteries will be eligible. They will be stratified at entry according to their metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance dose (chronic effects).
Study end-points:
A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.
B. Secondary biological end-points:
C. Secondary clinical end-points: To study the relationship between SIPA levels (and the other tests of platelet aggregation/activation) and the occurrence of:
We, the researchers at Assistance Publique - Hôpitaux de Paris, anticipate our study may help improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients treated with DES.
Condition | Intervention |
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Coronary Artery Disease Atherosclerosis Diabetes Mellitus Metabolic Syndrome X |
Procedure: blood samples before percutaneous coronary intervention (PCI) and at 4 months |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Biological Efficacy of Clopidogrel 600 mg Loading Dose Followed by 75 mg Maintenance Dose After Implantation of Drug-Eluting Stents in Patients With Diabetes Mellitus or Metabolic Syndrome (SPACE) |
Estimated Enrollment: | 220 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2008 |
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 recommended that all patients take an association of aspirin and clopidogrel for several months after DES implantation to reduce this risk. However, the biological efficacy of current antiplatelet therapies has not been studied prospectively and specifically in DM or MS patients.
In the present study, we will study the biological efficacy of an association of aspirin and clopidogrel (600 mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo shear-induced platelet aggregation (SIPA), along with other assays measuring platelet activation and aggregation, in order to better describe the heterogeneity of response to antiplatelet agents in patients with DM, MS or no DM/MS.
All patients with stable coronary artery disease and successful DES implantation in native coronary arteries (including high risk features, eg, left main stenosis, bifurcations or in-stent restenosis) will be eligible. They will be stratified at entry according to their metabolic status (DM, MS, or no DM/MS). Measurements will be performed both 6-24 hours after clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance dose (chronic effects).
Study end-points:
A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients.
B. Secondary biological end-points:
C. Secondary clinical end-points: To study the relationship between SIPA levels (and the other tests of platelet aggregation/activation) and the occurrence of:
We anticipate our study may help improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients treated with DES.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurent J Feldman, MD, PhD | +33 1 40 25 66 01 | laurent.feldman@bch.aphp.fr |
Contact: Nadine Ajzenberg, MD, PhD | +33 1 40 25 62 73 | nadine.ajzenberg@bch.aphp.fr |
France | |
Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris | Recruiting |
Paris, France, 75018 | |
Contact: Laurent J Feldman, MD, PhD +33 1 40 25 66 01 laurent.feldman@bch.aphp.fr | |
Contact: Gabriel Steg, MD +33 1 40 25 86 68 gabriel.steg@bch.aphp.fr | |
Sub-Investigator: Grégory Ducrocq, MD | |
Principal Investigator: Laurent J Feldman, MD,PhD | |
Sub-Investigator: Gabriel Steg, MD | |
Sub-Investigator: Jean-Michel Juliard, MD | |
Sub-Investigator: Dominique Himbert, MD | |
Sub-Investigator: Antoine Sauguet, MD | |
Sub-Investigator: Didier Tchétché, MD | |
Sub-Investigator: Pierre Aubry, MD | |
Sub-Investigator: Hakim Benamer, MD | |
Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris | Recruiting |
Paris, France, 75018 | |
Contact: Nadine Ajzenberg, MD, PhD +33 1 40 25 62 73 nadine.ajzenberg@bch.aphp.fr | |
Principal Investigator: Nadine Ajzenberg, MD, PhD |
Principal Investigator: | Laurent J Feldman, MD, PhD | Département de Cardiologie, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris |
Principal Investigator: | Nadine Ajzenberg, MD, PhD | Service d'Hématologie et d'Immunologie Biologiques, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris |
Study ID Numbers: | P051004 |
Study First Received: | March 1, 2006 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00298428 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
stent percutaneous coronary intervention platelet aggregation |
clopidogrel shear metabolic syndrome |
Atherosclerosis Arterial Occlusive Diseases Metabolic Syndrome X Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Arteriosclerosis Ischemia |
Coronary Disease Hyperinsulinism Clopidogrel Syndrome X Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Abdominal obesity metabolic syndrome Coronary Artery Disease |
Pathologic Processes Disease Therapeutic Uses Syndrome |
Hematologic Agents Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |