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

Cardiovascular Research Center, Brazil

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01113372

OPTIMIZE

Details and patient eligibility

About

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.

Enrollment: 3,119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients >18 years of age,
2. clinical indication for PCI with stent implantation of at least one angiographically documented coronary artery lesion,
3. 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

1. ST-elevation acute MI presenting for primary or rescue PCI;
2. DES in-stent restenosis;
3. PCI with bare metal stents <6 months prior to index procedure;
4. previous treatment with any DES;
5. scheduled elective surgery within 12 months post index procedure;
6. contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel;
7. known illness with life expectancy <36 months; and impossibility to comply with all protocol follow-ups.
8. target lesion(s) located in saphenous vein grafts,
9. coronary anatomy unsuitable for percutaneous treatment with implantation of the Endeavor ZES.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,119 participants in 2 patient groups

Clopidogrel 3 months

Experimental group

Description:

Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.

Treatment:

Drug: Clopidogrel

Clopidogrel 12 months

Active Comparator group

Description:

Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.

Treatment:

Drug: Clopidogrel