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

NCT ID: NCT01113372

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Coronary Artery Disease

Keywords

Coronary, Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Clopidogrel 3 months

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

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75mg daily.

Clopidogrel 12 months

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75mg daily.

Interventions

Clopidogrel

Clopidogrel 75mg daily.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiovascular Research Center, Brazil

OTHER

Sponsor Role: lead

Medtronic

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fausto Feres, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

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

Belo Horizonte, Minas Gerais, Brazil

Universidade Federal do Triangulo Mineiro

Uberaba, Minas Gerais, Brazil

Instituto do Coração do Triângulo Mineiro

Uberlândia, Minas Gerais, Brazil

Cardiocenter

João Pessoa, Paraíba, Brazil

Centro Integrado de Medicina Intervencionista

Belém, Pará, Brazil

Hospital Agamenon Magalhães

Recife, Pernambuco, Brazil

Procape

Recife, Pernambuco, Brazil

Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUC

Porto Alegre, Rio Grande do Sul, Brazil

Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Santa Isabel

Blumenau, Santa Catarina, Brazil

Instituto de Cardiologia de Santa Catarina

Florianópolis, Santa Catarina, Brazil

Cardiologia Catanduva

Catanduva, São Paulo, Brazil

Santa Casa de Limeira

Limeira, São Paulo, Brazil

Santa Casa de Marília

Marília, São Paulo, Brazil

INCORPI - Hosp. Fornecedores de Cana

Piracicaba, São Paulo, Brazil

Santa Casa de São Carlos

São Carlos, São Paulo, Brazil

Fundação Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Hospital Beneficência Portuguesa

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE

São Paulo, São Paulo, Brazil

EMCOR Emergências do Coração

Piracicaba, São Paulo - SP, Brazil

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo - SP, Brazil

INTERVECENTER Serviços Cardiovasculares

Palmas, Tocantins, Brazil

Countries

Brazil

References

Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, King SB 3rd, Negoita M, Liu M, de Paula JE, Mangione JA, Meireles GX, Castello HJ Jr, Nicolela EL Jr, Perin MA, Devito FS, Labrunie A, Salvadori D Jr, Gusmao M, Staico R, Costa JR Jr, de Castro JP, Abizaid AS, Bhatt DL; OPTIMIZE Trial Investigators. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. JAMA. 2013 Dec 18;310(23):2510-22. doi: 10.1001/jama.2013.282183.

Reference Type: DERIVED

PMID: 24177257 (View on PubMed)

Feres F, Costa RA, Bhatt DL, Leon MB, Botelho RV, King SB 3rd, de Paula JE, Mangione JA, Salvadori D Jr, Gusmao MO, Castello H Jr, Nicolela E Jr, Perin MA, Devito FS, Marin-Neto JA, Abizaid A. Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study. Am Heart J. 2012 Dec;164(6):810-6.e3. doi: 10.1016/j.ahj.2012.09.009. Epub 2012 Nov 14.

Reference Type: DERIVED

PMID: 23194480 (View on PubMed)

Other Identifiers

OPTIMIZE

Identifier Type: -

Identifier Source: org_study_id