Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Incidence Des évènements cArdiovasculaires majeurS Chez Les Patients COronariens diabétiques Subissant Une angioPlastie Coronaire et traités Par Clopidogrel à la Dose 150 mg Versus 75 mg
Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that
results in a platelet aggregation reaction in the coronary artery. The administration of
antiplatelet agents starting from the acute phase of the disease has helped reduce the risk
of ischemic relapse both during initial and long-term hospitalization.
Management of clopidogrel following an ischemic event has been the subject of several
treatment regimens ranging from a single continuous dose to a sequential double dose of
between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel
double dose in reducing the risk of myocardial intervention (MI) and the composite outcome:
cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was
interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected
patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty.
The literature describes an increased cardiovascular risk in type II diabetics in secondary
prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1
month on the reduction of this risk in the long-term in diabetic patients.
Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel
double dose, given for 1 month in ACS in the diabetic patient.
The study is an open label, multicentric clinical trial. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation). ;
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