Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial (OPTIMIZE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier:
NCT01113372
First received: April 22, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Center, Brazil:

Primary Outcome Measures:
  • NACCE [ Time Frame: 12 months clinical follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: until 24 and 36 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) and target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3120
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel 3 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Drug: Clopidogrel
Clopidogrel 75mg daily.
Active Comparator: Clopidogrel 12 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
Drug: Clopidogrel
Clopidogrel 75mg daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113372

Locations
Brazil
Hospital Anchieta
Brasília, DF, Brazil
Hospital do Coração do Brasil
Brasília, Distrito Federal, Brazil
UNICOR
Linhares, ES, Brazil
Centro de Estudos Clínicos
Belo Horizonte, MG, Brazil
Hospital Lifecenter
Belo Horizonte, MG, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, MG, Brazil
Universidade Federal do Triangulo Mineiro
Uberaba, MG, Brazil
Instituto do Coração do Triângulo Mineiro
Uberlândia, MG, Brazil
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro Integrado de Medicina Intervencionista
Belém, PA, Brazil
Cardiocenter
João Pessoa, PB, Brazil
Hospital Agamenon Magalhães
Recife, PE, Brazil
Procape
Recife, PE, Brazil
Hospital São Lucas da PUC
Porto Alegre, RS, Brazil
Santa Casa de Porto Alegre
Porto Alegre, RS, Brazil
Hospital Mãe de Deus
Porto Alegre, RS, Brazil
Fundação Universitária de Cardiologia
Porto Alegre, RS, Brazil
Hospital Santa Isabel
Blumenau, SC, Brazil
Instituto de Cardiologia de Santa Catarina
Florianópolis, SC, Brazil
Cardiologia Catanduva
Catanduva, SP, Brazil
Santa Casa de Limeira
Limeira, SP, Brazil
Santa Casa de Marília
Marília, SP, Brazil
INCORPI - Hosp. Fornecedores de Cana
Piracicaba, SP, Brazil
Santa Casa de São Carlos
São Carlos, SP, Brazil
Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE
São Paulo, SP, Brazil
Hospital Beneficência Portuguesa
São Paulo, SP, Brazil
Hospital Bandeirantes
São Paulo, SP, Brazil
Hospital Santa Marcelina
São Paulo, SP, Brazil
EMCOR Emergências do Coração
Piracicaba, São Paulo - SP, Brazil
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo - SP, Brazil
Fundação Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
INTERVECENTER Serviços Cardiovasculares
Palmas, TO, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-180
Sponsors and Collaborators
Cardiovascular Research Center, Brazil
Medtronic
Investigators
Principal Investigator: Fausto Feres, PhD Instituto Dante Pazzanese de Cardiologia
  More Information

No publications provided by Cardiovascular Research Center, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexandre Abizaid, MD, Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier: NCT01113372     History of Changes
Other Study ID Numbers: OPTIMIZE
Study First Received: April 22, 2010
Last Updated: November 27, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Cardiovascular Research Center, Brazil:
Coronary, Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014