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Completed

NCT Number: NCT01113372

Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNICOR, Linhares, Espírito Santo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75mg daily.

Primary outcomes

  1. NACCE

    Time frame: 12 months clinical follow-up

    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 outcomes

  1. Rates of Stent thrombosis

    Time frame: until 24 and 36 months

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

    Time frame: 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)

    Time frame: 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

    Time frame: until 12 months

Sponsors and collaborators

Lead sponsor

Cardiovascular Research Center, Brazil

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: OPTIMIZE

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Apr 29, 2010
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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