NCT01293773

Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Policlinico Casilino ASL RMB · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Coronary Artery Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Taxus Element stent	paclitaxel-eluting stent
DEVICE	Integrity Resolute stent	ABT 578-eluting stent
DEVICE	Xience Prime stent	Everolimus-eluting stent

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-02-11
• Last updated: 2014-11-07

Locations

2 sites across 1 country: Italy