Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 29, 2010
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
  • Rates of Stent thrombosis [ Time Frame: until 24 and 36 months ]
  • Target vessel revascularization (TVR) and target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial
Official Title  ICMJE Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Clopidogrel
Clopidogrel 75mg daily.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2015)
3119
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2010)
3120
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01113372
Other Study ID Numbers  ICMJE OPTIMIZE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cardiovascular Research Center, Brazil
Study Sponsor  ICMJE Cardiovascular Research Center, Brazil
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Fausto Feres, PhD Instituto Dante Pazzanese de Cardiologia
PRS Account Cardiovascular Research Center, Brazil
Verification Date December 2015

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