Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent|
- Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ]
- The individual components of the primary endpoint [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Clopidogrel||
Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
|Placebo Comparator: Placebo||
Patients randomized in this group will receive placebo for 6 months.
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.
|Contact: Julinda Mehilli, MD||49-89-1218 ext email@example.com|
|Contact: Stefanie Schulz, MD||49-89-1218 ext firstname.lastname@example.org|
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|Study Chair:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Julinda Mehilli, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Jurriёn M ten Berg, MD||Department of Cardiology; St. Antonius Hospital; 3435 CM Nieuwegein; The Netherlands|