Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 11:33 AM
Study NCT ID:
NCT00944333
Status:
TERMINATED
Last Update Posted:
2014-08-05
First Post:
2009-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Organization:
Study Overview
Official Title:
Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: