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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier:
NCT01113372
First received: April 22, 2010
Last updated: November 27, 2012
Last verified: November 2012

April 22, 2010
November 27, 2012
April 2010
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01113372 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Coronary Artery Disease
Drug: Clopidogrel
Clopidogrel 75mg daily.
  • Experimental: Clopidogrel 3 months
    Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
    Intervention: Drug: Clopidogrel
  • Active Comparator: Clopidogrel 12 months
    Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
    Intervention: Drug: Clopidogrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3120
April 2015
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01113372
OPTIMIZE
Yes
Alexandre Abizaid, MD, Cardiovascular Research Center, Brazil
Cardiovascular Research Center, Brazil
Medtronic
Principal Investigator: Fausto Feres, PhD Instituto Dante Pazzanese de Cardiologia
Cardiovascular Research Center, Brazil
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP