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

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ClinicalTrials.gov Identifier: NCT01113372
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Cardiovascular Research Center, Brazil

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113372


Locations
Show Show 32 study locations
Sponsors and Collaborators
Cardiovascular Research Center, Brazil
Medtronic
Investigators
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Principal Investigator: Fausto Feres, PhD Instituto Dante Pazzanese de Cardiologia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier: NCT01113372    
Other Study ID Numbers: OPTIMIZE
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Cardiovascular Research Center, Brazil:
Coronary, Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs