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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
Cardiovascular Research Center, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Coronary, Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Anchieta
  • Hospital do Coração do Brasil
  • UNICOR
  • Hospital Lifecenter
  • Santa Casa de Belo Horizonte
  • Universidade Federal do Triangulo Mineiro
  • Instituto do Coração do Triângulo Mineiro
  • Hospital Felício Rocho
  • Centro Integrado de Medicina Intervencionista
  • Cardiocenter
  • Hospital Agamenon Magalhães
  • Procape
  • Fundação Universitária de Cardiologia
  • Hospital Mãe de Deus
  • Hospital São Lucas da PUC
  • Santa Casa de Porto Alegre
  • Hospital Santa Isabel
  • Instituto de Cardiologia de Santa Catarina
  • Cardiologia Catanduva
  • Santa Casa de Limeira
  • Santa Casa de Marília
  • INCORPI - Hosp. Fornecedores de Cana
  • Santa Casa de São Carlos
  • Hospital Bandeirantes
  • Hospital Beneficência Portuguesa
  • Hospital Santa Marcelina
  • Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE
  • EMCOR Emergências do Coração
  • Hospital das Clínicas de Ribeirão Preto
  • Fundação Regional de Medicina de São José do Rio Preto
  • INTERVECENTER Serviços Cardiovasculares
  • Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clopidogrel 3 months

Clopidogrel 12 months

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rates of Stent thrombosis
Target vessel revascularization (TVR) and target lesion revascularization (TLR)
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)
Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up

Full Information

First Posted
April 22, 2010
Last Updated
December 17, 2015
Sponsor
Cardiovascular Research Center, Brazil
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01113372
Brief Title
Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial
Acronym
OPTIMIZE
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiovascular Research Center, Brazil
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary, Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel 3 months
Arm Type
Experimental
Arm Description
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Arm Title
Clopidogrel 12 months
Arm Type
Active Comparator
Arm Description
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 75mg daily.
Primary Outcome Measure Information:
Title
NACCE
Description
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 Outcome Measure Information:
Title
Rates of Stent thrombosis
Time Frame
until 24 and 36 months
Title
Target vessel revascularization (TVR) and target lesion revascularization (TLR)
Time Frame
6 and 12 months
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto Feres, PhD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Anchieta
City
Brasília
State/Province
DF
Country
Brazil
Facility Name
Hospital do Coração do Brasil
City
Brasília
State/Province
Distrito Federal
Country
Brazil
Facility Name
UNICOR
City
Linhares
State/Province
ES
Country
Brazil
Facility Name
Hospital Lifecenter
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Santa Casa de Belo Horizonte
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Universidade Federal do Triangulo Mineiro
City
Uberaba
State/Province
MG
Country
Brazil
Facility Name
Instituto do Coração do Triângulo Mineiro
City
Uberlândia
State/Province
MG
Country
Brazil
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Centro Integrado de Medicina Intervencionista
City
Belém
State/Province
PA
Country
Brazil
Facility Name
Cardiocenter
City
João Pessoa
State/Province
PB
Country
Brazil
Facility Name
Hospital Agamenon Magalhães
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Procape
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital São Lucas da PUC
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Santa Casa de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Santa Isabel
City
Blumenau
State/Province
SC
Country
Brazil
Facility Name
Instituto de Cardiologia de Santa Catarina
City
Florianópolis
State/Province
SC
Country
Brazil
Facility Name
Cardiologia Catanduva
City
Catanduva
State/Province
SP
Country
Brazil
Facility Name
Santa Casa de Limeira
City
Limeira
State/Province
SP
Country
Brazil
Facility Name
Santa Casa de Marília
City
Marília
State/Province
SP
Country
Brazil
Facility Name
INCORPI - Hosp. Fornecedores de Cana
City
Piracicaba
State/Province
SP
Country
Brazil
Facility Name
Santa Casa de São Carlos
City
São Carlos
State/Province
SP
Country
Brazil
Facility Name
Hospital Bandeirantes
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital Beneficência Portuguesa
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
EMCOR Emergências do Coração
City
Piracicaba
State/Province
São Paulo - SP
Country
Brazil
Facility Name
Hospital das Clínicas de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo - SP
Country
Brazil
Facility Name
Fundação Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
INTERVECENTER Serviços Cardiovasculares
City
Palmas
State/Province
TO
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
04012-180
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24177257
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.
Results Reference
derived
PubMed Identifier
23194480
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.
Results Reference
derived

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

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