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

Cardiovascular Research Center, Brazil3,119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

3,119

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (32)

UNICOR

Linhares, Espírito Santo, Brazil

Hospital Anchieta

Brasília, Federal District, Brazil

Hospital do Coração do Brasil

Brasília, Federal District, Brazil

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, Brazil

Hospital Lifecenter

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Belo Horizonte

Outcomes

Primary Outcomes

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.

Time frame: 12 months clinical follow-up

Secondary Outcomes

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