Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial
OPTIMIZE
1 other identifier
interventional
3,119
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Apr 2010
Longer than P75 for phase_4 coronary-artery-disease
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 18, 2015
December 1, 2015
2.8 years
April 22, 2010
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Clopidogrel 3 months
EXPERIMENTALRegime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Clopidogrel 12 months
ACTIVE COMPARATORRegime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiovascular Research Center, Brazillead
- Medtroniccollaborator
Study Sites (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
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, 04012-180, 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
Related Publications (2)
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.
PMID: 24177257DERIVEDFeres 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.
PMID: 23194480DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fausto Feres, PhD
Instituto Dante Pazzanese de Cardiologia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 29, 2010
Study Start
April 1, 2010
Primary Completion
February 1, 2013
Study Completion
July 1, 2015
Last Updated
December 18, 2015
Record last verified: 2015-12