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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy|
- Definite and/or probable stent thrombosis occurring between 6 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Composite of major adverse cardiac events (MACE) defined as the occurrence at 24 months of cardiac death, or myocardial infarction, or urgent target vessel revascularization (cardiac bypass surgery, or repeat PTCA) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Clopidogrel 6
6 month dual antiplatelet therapies in patients after second generation DES implantation
300-600 loading dose 75 mg/die for 6 months
Experimental: Clopidogrel 12
12 month dual antiplatelet therapies in patients after second generation DES implantation
300-600 loading dose 75 mg/die for 12 months
|Contact: Monica Repetto, Dr.||02.34535088 ext firstname.lastname@example.org|
|Irccs Fondazione Centro S. Raffaele Del Monte Tabor -||Recruiting|
|Milano (mi), Italy, 20132|
|Contact: Antonio Colombo, Dr. 02.26437331 email@example.com|
|Contact: Alaide Chieffo, Dr. 02.26437331 firstname.lastname@example.org|
|Principal Investigator: Maurizio Tespili, Dr.|
|Principal Investigator: Gennaro Sardella, Prof.|
|Principal Investigator: Patrizia Presbitero|
|Principal Investigator: Giorgio Binetti, Dr.|
|Principal Investigator: Cataldo Palmieri, Dr.|
|Principal Investigator: Corrado Tamburino, Dr.|
|Principal Investigator: Amerigo Stabile, Dr.|
|Principal Investigator: Giuseppe Carosio, Prof.|