Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial

Study Overview
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Brief Summary
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Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected patients from the real-world clinical practice receiving the Endeavor ZES for the treatment of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day for 3 months versus 12 months.

Official Title
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Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients >18 years of age, clinical indication for PCI with stent implantation of at least one angiographically documented coronary artery lesion, agreement to undergo all protocol clinical follow-ups. 4 - presence of at least one obstruction >50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with coronary anatomy suitable for percutaneous treatment with implantation of the Endeavor ZES. Exclusion Criteria: ST-elevation acute MI presenting for primary or rescue PCI; DES in-stent restenosis; PCI with bare metal stents <6 months prior to index procedure; previous treatment with any DES; scheduled elective surgery within 12 months post index procedure; contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel; known illness with life expectancy <36 months; and impossibility to comply with all protocol follow-ups. target lesion(s) located in saphenous vein grafts, coronary anatomy unsuitable for percutaneous treatment with implantation of the Endeavor ZES.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel 3 months<br>Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months. | Drug: Clopidogrel<br>* Clopidogrel 75mg daily.<br>|
| Active Comparator: Clopidogrel 12 months<br>Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months. | Drug: Clopidogrel<br>* Clopidogrel 75mg daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NACCE | 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. | 12 months clinical follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Stent thrombosis |  | until 24 and 36 months | 
| Target vessel revascularization (TVR) and target lesion revascularization (TLR) |  | 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) |  | until 36 months | 
| Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up |  | until 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary, Disease