Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial - Full Text View

Sponsor:	Cardiovascular Research Center, Brazil
Collaborator:	Medtronic
Information provided by:	Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier:	NCT01113372

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 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

Contacts

Contact: Fausto Feres, MD, PhD

55 11 5083 1001

faustoferes.optimize@gmail.com

Locations

Brazil
Hospital Anchieta	Recruiting
Brasília, DF, Brazil
Principal Investigator: Paulo Motta
Hospital do Coração do Brasil	Active, not recruiting
Brasília, Distrito Federal, Brazil
UNICOR	Recruiting
Linhares, ES, Brazil
Principal Investigator: João Eduardo Tinoco
Centro de Estudos Clínicos	Not yet recruiting
Belo Horizonte, MG, Brazil
Contact: João Lisboa
Principal Investigator: João Dias
Hospital Lifecenter	Active, not recruiting
Belo Horizonte, MG, Brazil
Santa Casa de Belo Horizonte	Active, not recruiting
Belo Horizonte, MG, Brazil
Universidade Federal do Triangulo Mineiro	Recruiting
Uberaba, MG, Brazil
Contact: Rone Padilha
Instituto do Coração do Triângulo Mineiro	Recruiting
Uberlândia, MG, Brazil
Principal Investigator: Roberto Botelho
Hospital Felício Rocho	Active, not recruiting
Belo Horizonte, Minas Gerais, Brazil
Centro Integrado de Medicina Intervencionista	Recruiting
Belém, PA, Brazil
Contact: Heloiza Silva
Principal Investigator: Heloisa Melo Silva
Cardiocenter	Recruiting
João Pessoa, PB, Brazil
Contact: Helman Martins
Principal Investigator: Helman Martins
Hospital Agamenon Magalhães	Recruiting
Recife, PE, Brazil
Principal Investigator: Marcos Gusmão
Procape	Recruiting
Recife, PE, Brazil
Contact: Nelson Araujo
Principal Investigator: Nelson Araujo
Hospital São Lucas da PUC	Recruiting
Porto Alegre, RS, Brazil
Principal Investigator: Paulo Caramori
Santa Casa de Porto Alegre	Active, not recruiting
Porto Alegre, RS, Brazil
Hospital Mãe de Deus	Recruiting
Porto Alegre, RS, Brazil
Principal Investigator: Alexandre Zago
Fundação Universitária de Cardiologia	Recruiting
Porto Alegre, RS, Brazil
Contact: Rogério Sarmento
Principal Investigator: Rogério Sarmento Leite
Hospital Santa Isabel	Recruiting
Blumenau, SC, Brazil
Contact: Adrian Korman
Principal Investigator: Adrian Kormann
Instituto de Cardiologia de Santa Catarina	Active, not recruiting
Florianópolis, SC, Brazil
Cardiologia Catanduva	Recruiting
Catanduva, SP, Brazil
Principal Investigator: Fenando Devito
Santa Casa de Limeira	Recruiting
Limeira, SP, Brazil
Principal Investigator: Pablo Teixeirense
Santa Casa de Marília	Recruiting
Marília, SP, Brazil
Principal Investigator: André Labrunie
Principal Investigator: Marden Tebet
INCORPI - Hosp. Fornecedores de Cana	Recruiting
Piracicaba, SP, Brazil
Principal Investigator: Pablo Teixeirense
Santa Casa de São Carlos	Recruiting
São Carlos, SP, Brazil
Principal Investigator: Sérgio Berti
Hospital Beneficência Portuguesa	Recruiting
São Paulo, SP, Brazil
Principal Investigator: Decio Salvadori
Principal Investigator: José Mangione
Hospital Bandeirantes	Recruiting
São Paulo, SP, Brazil
Principal Investigator: Hélio Castello
Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE	Recruiting
São Paulo, SP, Brazil
Principal Investigator: George Ximenes
Hospital Santa Marcelina	Recruiting
São Paulo, SP, Brazil
Contact: Marco perin
Principal Investigator: Marco Perin
EMCOR Emergências do Coração	Recruiting
Piracicaba, São Paulo - SP, Brazil
Principal Investigator: Eduardo Nicolela
Hospital das Clínicas de Ribeirão Preto	Recruiting
Ribeirão Preto, São Paulo - SP, Brazil
Principal Investigator: J. A. Marin-Neto
INTERVECENTER Serviços Cardiovasculares	Recruiting
Palmas, TO, Brazil
Principal Investigator: Andrés Sanchez
Instituto Dante Pazzanese de Cardiologia	Recruiting
São Paulo, Brazil, 04012-180
Contact: Fausto Feres, MD
Principal Investigator: Fausto Feres, MD

Sponsors and Collaborators

Cardiovascular Research Center, Brazil

Medtronic

Investigators

Principal Investigator:

Fausto Feres, PhD

Instituto Dante Pazzanese de Cardiologia

More Information

No publications provided

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:	June 13, 2011
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 23, 2012