Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-09 @ 1:59 AM
Study NCT ID:
NCT00661206
Status:
UNKNOWN
Last Update Posted:
2014-10-09
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISAR-SAFE
Brief Summary:
The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.
Detailed Description:
Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.
Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.
Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.
Study Oversight
Has Oversight DMC:
True
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?: