NCT00944333|TerminatedPhase 3
Study Stopped
STOP due to recent data in literature questioning the need to continue DAP beyond six months in patients with stable coronary artery stenting with DES.
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STOP due to recent data in literature questioning the need to continue DAP beyond six months in patients with stable coronary artery stenting with DES.
Sponsor study identifier
interventional
1,378
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 22, 2009
Actual (reported)July 23, 2009
Actual (reported)June 2014
Actual (reported)July 2014
Actual (reported)Definite and/or probable stent thrombosis occurring between 6 and 24 months
24 months
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)
24 months
6 month dual antiplatelet therapies in patients after second generation DES implantation
12 month dual antiplatelet therapies in patients after second generation DES implantation
300-600 loading dose 75 mg/die for 6 months
300-600 loading dose 75 mg/die for 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Irccs Fondazione Centro S. Raffaele Del Monte Tabor -
Milano (mi), 20132, Italy
Colombo A, Chieffo A, Frasheri A, Garbo R, Masotti-Centol M, Salvatella N, Oteo Dominguez JF, Steffanon L, Tarantini G, Presbitero P, Menozzi A, Pucci E, Mauri J, Cesana BM, Giustino G, Sardella G. Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2086-97. doi: 10.1016/j.jacc.2014.09.008. Epub 2014 Sep 15.
1,378 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2009
First Posted
July 23, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
August 5, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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