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

Coronary Artery Disease Clinical Trial

— OPTIMIZE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113372
• Other study ID #: OPTIMIZE
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2010
• Last updated: December 17, 2015
• Start date: April 2010
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Cardiovascular Research Center, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3119
• Est. completion date: July 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
Clopidogrel 75mg daily.

Locations

Country	Name	City	State
Brazil	Centro Integrado de Medicina Intervencionista	Belém	PA
Brazil	Hospital Felício Rocho	Belo Horizonte	Minas Gerais
Brazil	Hospital Lifecenter	Belo Horizonte	MG
Brazil	Santa Casa de Belo Horizonte	Belo Horizonte	MG
Brazil	Hospital Santa Isabel	Blumenau	SC
Brazil	Hospital Anchieta	Brasília	DF
Brazil	Hospital do Coração do Brasil	Brasília	Distrito Federal
Brazil	Cardiologia Catanduva	Catanduva	SP
Brazil	Instituto de Cardiologia de Santa Catarina	Florianópolis	SC
Brazil	Cardiocenter	João Pessoa	PB
Brazil	Santa Casa de Limeira	Limeira	SP
Brazil	UNICOR	Linhares	ES
Brazil	Santa Casa de Marília	Marília	SP
Brazil	INTERVECENTER Serviços Cardiovasculares	Palmas	TO
Brazil	EMCOR Emergências do Coração	Piracicaba	São Paulo - SP
Brazil	INCORPI - Hosp. Fornecedores de Cana	Piracicaba	SP
Brazil	Fundação Universitária de Cardiologia	Porto Alegre	RS
Brazil	Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Hospital São Lucas da PUC	Porto Alegre	RS
Brazil	Santa Casa de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Agamenon Magalhães	Recife	PE
Brazil	Procape	Recife	PE
Brazil	Hospital das Clínicas de Ribeirão Preto	Ribeirão Preto	São Paulo - SP
Brazil	Santa Casa de São Carlos	São Carlos	SP
Brazil	Fundação Regional de Medicina de São José do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Hospital Bandeirantes	São Paulo	SP
Brazil	Hospital Beneficência Portuguesa	São Paulo	SP
Brazil	Hospital Santa Marcelina	São Paulo	SP
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE	São Paulo	SP
Brazil	Universidade Federal do Triangulo Mineiro	Uberaba	MG
Brazil	Instituto do Coração do Triângulo Mineiro	Uberlândia	MG

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Research Center, Brazil	Medtronic

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months clinical follow-up	Yes
Secondary	Rates of Stent thrombosis		until 24 and 36 months	Yes
Secondary	Target vessel revascularization (TVR) and target lesion revascularization (TLR)		6 and 12 months	No
Secondary	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)		until 36 months	Yes
Secondary	Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up		until 12 months	Yes