Clinical trial NCT01113372: Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial
Official title: Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary, Disease
Lead sponsor: Cardiovascular Research Center, Brazil
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-04-29
Enrollment: 3119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: NACCE
timeFrame: 12 months clinical follow-up
Secondary outcomes:
measure: Rates of Stent thrombosis
timeFrame: until 24 and 36 months
measure: Target vessel revascularization (TVR) and target lesion revascularization (TLR)
timeFrame: 6 and 12 months
measure: 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)
timeFrame: until 36 months
measure: Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up
timeFrame: until 12 months
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Anchieta
state: DF
city: Brasília
country: Brazil
facility: Hospital do Coração do Brasil
state: Distrito Federal
city: Linhares
country: Brazil
facility: UNICOR
state: ES
city: Belo Horizonte
country: Brazil
facility: Hospital Lifecenter
state: MG
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte
state: MG
city: Uberaba
country: Brazil
facility: Universidade Federal do Triangulo Mineiro
state: MG
city: Uberlândia
country: Brazil
facility: Instituto do Coração do Triângulo Mineiro
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
state: Minas Gerais
city: Belém
country: Brazil
facility: Centro Integrado de Medicina Intervencionista
state: PA
city: João Pessoa
country: Brazil
facility: Cardiocenter
state: PB
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães
state: PE
city: Recife
country: Brazil
facility: Procape
state: PE
city: Porto Alegre
country: Brazil
facility: Fundação Universitária de Cardiologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUC
state: RS
city: Porto Alegre
country: Brazil
facility: Santa Casa de Porto Alegre
state: RS
city: Blumenau
country: Brazil
facility: Hospital Santa Isabel
state: SC
city: Florianópolis
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: SC
city: Catanduva
country: Brazil
facility: Cardiologia Catanduva
state: SP
city: Limeira
country: Brazil
facility: Santa Casa de Limeira
state: SP
city: Marília
country: Brazil
facility: Santa Casa de Marília
state: SP
city: Piracicaba
country: Brazil
facility: INCORPI - Hosp. Fornecedores de Cana
state: SP
city: São Carlos
country: Brazil
facility: Santa Casa de São Carlos
state: SP
city: São Paulo
country: Brazil
facility: Hospital Bandeirantes
state: SP
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa
state: SP
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE
state: SP
city: Piracicaba
country: Brazil
facility: EMCOR Emergências do Coração
state: São Paulo - SP
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto
state: São Paulo - SP
city: São José do Rio Preto
country: Brazil
facility: Fundação Regional de Medicina de São José do Rio Preto
state: São Paulo
city: Palmas
country: Brazil
facility: INTERVECENTER Serviços Cardiovasculares
state: TO
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Fausto Feres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.