Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus