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:
Cardiovascular Research Center, Brazil
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
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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:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Clopidogrel bisulfate
U.S. FDA Resources
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:
- 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.
Contacts and Locations
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 May 22, 2013