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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Clopidogrel

• Registration Number: NCT01113372
• Lead Sponsor: Cardiovascular Research Center, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Primary Completion: 2013-02
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel 3 months	Clopidogrel	Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Clopidogrel 12 months	Clopidogrel	Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.

Primary Outcome Measures

Name	Time	Method
NACCE	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (32)

Hospital Anchieta; 🇧🇷 Brasília, DF, Brazil

Universidade Federal do Triangulo Mineiro; 🇧🇷 Uberaba, MG, Brazil

Instituto do Coração do Triângulo Mineiro; 🇧🇷 Uberlândia, MG, Brazil

Instituto de Cardiologia de Santa Catarina; 🇧🇷 Florianópolis, SC, Brazil

Santa Casa de São Carlos; 🇧🇷 São Carlos, SP, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, Brazil

Fundação Regional de Medicina de São José do Rio Preto; 🇧🇷 São José do Rio Preto, São Paulo, Brazil

EMCOR Emergências do Coração; 🇧🇷 Piracicaba, São Paulo - SP, Brazil

Hospital São Lucas da PUC; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Bandeirantes; 🇧🇷 São Paulo, SP, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, SP, Brazil

Hospital Felício Rocho; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Limeira; 🇧🇷 Limeira, SP, Brazil

Hospital das Clínicas de Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo - SP, Brazil

UNICOR; 🇧🇷 Linhares, ES, Brazil

Santa Casa de Belo Horizonte; 🇧🇷 Belo Horizonte, MG, Brazil

Centro Integrado de Medicina Intervencionista; 🇧🇷 Belém, PA, Brazil

Hospital Agamenon Magalhães; 🇧🇷 Recife, PE, Brazil

Fundação Universitária de Cardiologia; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Santa Isabel; 🇧🇷 Blumenau, SC, Brazil

Hospital do Coração do Brasil; 🇧🇷 Brasília, Distrito Federal, Brazil

Santa Casa de Marília; 🇧🇷 Marília, SP, Brazil

INCORPI - Hosp. Fornecedores de Cana; 🇧🇷 Piracicaba, SP, Brazil

Hospital Beneficência Portuguesa; 🇧🇷 São Paulo, SP, Brazil

Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE; 🇧🇷 São Paulo, SP, Brazil

Hospital Lifecenter; 🇧🇷 Belo Horizonte, MG, Brazil

Cardiocenter; 🇧🇷 João Pessoa, PB, Brazil

Procape; 🇧🇷 Recife, PE, Brazil

Hospital Mãe de Deus; 🇧🇷 Porto Alegre, RS, Brazil

Santa Casa de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Cardiologia Catanduva; 🇧🇷 Catanduva, SP, Brazil

INTERVECENTER Serviços Cardiovasculares; 🇧🇷 Palmas, TO, Brazil