NCT00944333

Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,378 (actual)
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomized, non-inferiority, multicenter, international study.In total 4000 patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a second generation DES implantation. Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail). If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05 (two-tails). The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 % more thrombotic events has to be considered together with the lower expected number of bleeding events in the 6-months regimen. All the analysis will be done as "intention-to-treat" analysis.

Conditions

• Angina Pectoris
• Silent Ischemia

Interventions

Type	Name	Description
DRUG	Clopidogrel	300-600 loading dose 75 mg/die for 6 months
DRUG	Clopidogrel	300-600 loading dose 75 mg/die for 12 months

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2009-07-23
• Last updated: 2014-08-05

Locations

1 site across 1 country: Italy