Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)
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|ClinicalTrials.gov Identifier: NCT00661206|
Recruitment Status : Unknown
Verified October 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was: Active, not recruiting
First Posted : April 18, 2008
Last Update Posted : October 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Clopidogrel Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4005 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
|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.
- Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ]
- The individual components of the primary endpoint [ Time Frame: 9 months after randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661206
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|Study Chair:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Jurriёn M ten Berg, MD||St. Antonius Hospital Nieuwegein, Department of Cardiology|