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Coronary Artery DiseasePhase 4OPTIMIZENCT01113372

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

A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Cardiovascular Research Center, Brazil at 32 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,119 participants
Where
32 sitesBrazil
Study dates
Apr 2010to Jul 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Brazil32 sites

  • Centro Integrado de Medicina Intervencionista

    Belém, Pará

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais

  • Hospital Lifecenter

    Belo Horizonte, Minas Gerais

  • Santa Casa de Belo Horizonte

    Belo Horizonte, Minas Gerais

  • Hospital Santa Isabel

    Blumenau, Santa Catarina

  • Hospital Anchieta

    Brasília, Federal District

  • Hospital do Coração do Brasil

    Brasília, Federal District

  • Cardiologia Catanduva

    Catanduva, São Paulo

  • Instituto de Cardiologia de Santa Catarina

    Florianópolis, Santa Catarina

  • Cardiocenter

    João Pessoa, Paraíba

  • Santa Casa de Limeira

    Limeira, São Paulo

  • UNICOR

    Linhares, Espírito Santo

  • Santa Casa de Marília

    Marília, São Paulo

  • INTERVECENTER Serviços Cardiovasculares

    Palmas, Tocantins

  • INCORPI - Hosp. Fornecedores de Cana

    Piracicaba, São Paulo

  • EMCOR Emergências do Coração

    Piracicaba, São Paulo - SP

  • Fundação Universitária de Cardiologia

    Porto Alegre, Rio Grande do Sul

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul

  • Hospital São Lucas da PUC

    Porto Alegre, Rio Grande do Sul

  • Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Agamenon Magalhães

    Recife, Pernambuco

  • Procape

    Recife, Pernambuco

  • Hospital das Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo - SP

  • Santa Casa de São Carlos

    São Carlos, São Paulo

  • Fundação Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo, 04012-180

  • Hospital Bandeirantes

    São Paulo, São Paulo

  • Hospital Beneficência Portuguesa

    São Paulo, São Paulo

  • Hospital Santa Marcelina

    São Paulo, São Paulo

  • Instituto de Assistencia Médica ao Sevidor Público Estadual- IAMSPE

    São Paulo, São Paulo

  • Universidade Federal do Triangulo Mineiro

    Uberaba, Minas Gerais

  • Instituto do Coração do Triângulo Mineiro

    Uberlândia, Minas Gerais

Other trials in Brazil

About this study

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

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.

Being tested
Clopidogrel
Keywords
Coronary, Disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01113372
Study groupRoleWhat they receive
Clopidogrel 3 monthsExperimentalRegime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
Receives: Drug: Clopidogrel
Clopidogrel 12 monthsActive comparatorRegime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months clinical follow-up

Secondary outcomes (4)

  1. Rates of Stent thrombosis

    Measured: until 24 and 36 months

  2. Target vessel revascularization (TVR) and target lesion revascularization (TLR)

    Measured: 6 and 12 months

  3. 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)

    Measured: until 36 months

  4. Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up

    Measured: until 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionFeb 2013
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01113372
Sponsor's protocol ID
OPTIMIZE
Acronym
OPTIMIZE
Status last verified
Dec 2015
First submitted
22 Apr 2010
Last updated
18 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24177257

  • 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.

    PubMed 23194480

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Cardiovascular Research Center, Brazil at 32 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NACCE (time frame: 12 months clinical follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01113372, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.

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