Coronary Artery Disease Clinical Trial
Official title:
Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the
prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578-
versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with
de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.
Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary
End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death,
myocardial infarction and repeated lesion revascularization within 12 months.
Secondary End-Points: 1) impact of glucose level during the first three months following the
procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion
revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus
prolonged (> 12 months) of dual antiplatelet therapy
Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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