Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial (OPTIMIZE)
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|ClinicalTrials.gov Identifier: NCT01113372|
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : December 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||July 2015|
Experimental: Clopidogrel 3 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Clopidogrel 75mg daily.
Active Comparator: Clopidogrel 12 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
Clopidogrel 75mg daily.
- NACCE [ Time Frame: 12 months clinical follow-up ]rates of Net Clinical Benefit (net adverse clinical and cerebral events, NACCE) at 12 months clinical follow-up. The primary endpoint is defined as the composite endpoint of: death by any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria). The primary endpoint will be assessed only in patients receiving exclusively the Endeavor ZES during index (and staged) procedure.
- Rates of Stent thrombosis [ Time Frame: until 24 and 36 months ]
- Target vessel revascularization (TVR) and target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]
- MACE (major adverse cardiac events) at in-hospital, 30 days, 6, 12, 18, 24 and 36 months; DAPT compliance (according to treatment allocation in the trial) [ Time Frame: until 36 months ]
- Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up [ Time Frame: until 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113372
|Principal Investigator:||Fausto Feres, PhD||Instituto Dante Pazzanese de Cardiologia|