Angina Pectoris Clinical Trial
Official title:
Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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