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Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents (OPTIMA-C)

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ClinicalTrials.gov Identifier: NCT03056118
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Hyuck moon Kwon, Gangnam Severance Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 17, 2017
Actual Study Start Date  ICMJE May 2, 2011
Actual Primary Completion Date June 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR) [ Time Frame: 12 months ]
  1. Cardiac death: Any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
  2. MI Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
  3. TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated* or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents
Official Title  ICMJE Optimal Duration of Clopidogrel After Implantation of Second-Generation Drug-Eluting Stents (OPTIMA-C)
Brief Summary Investigators try to assess the safety of 6-months or 12-months maintenance of dual antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous coronary intervention using the Zotarolimus-eluting, Resolute Integrity™ stent (Medtronic Vascular Inc, Santa Rosa, CA) or the BioMatrix™ stent (Biosensors. Singapore).
Detailed Description

Dual antiplatelet therapy (DAPT) has proven the most effective treatment in reducing thrombotic complications after drug eluting stent (DES) implantation. Although the optimal duration of antiplatelet therapy is still under investigation, late stent thrombosis (ST) with DES has pushed the recommendation for duration of clopidogrel therapy for one year or more, in patients without risks for bleeding. However, recent controversies regarding the risk of stent thrombosis in patients receiving DES has brought up the issue of the appropriate duration of antiplatelet therapy after percutaneous coronary intervention, and a recent study reported that the use of extended DAPT for a period longer than 12 months in patients who had received DES was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction (MI) or death for cardiac causes.

Zotarolimus-eluting stent (Resolute Integrity™) and biolimus-eluting stent with biodegradable polymer system (BioMatrix™) share several similarities. Both stents are flexible thin strut stents eluting sirolimus-analogue drugs targeting at mammalian target of rapamycin. The advantages that Resolute Integrity™ stent strut is quite thin and coated with highly biocompatible polymer and BioMatrix™ stent has the abluminal drug coating system with biodegradable polymer might provide clinical studies showing that both stents are quite safe as well as efficacious. Moreover, recent report showed that continuation of clopidogrel for only 3 months after implantation of Endeavor stent seems to be safe in low-to-moderate coronary artery risk group. Based on these clinical evidences, the duration of DAPT continuation for 12 months or less after implantation of Resolute Integrity™ or BioMatrix™ stent, 'the second generation DES', would be safe, however, there are no data available about this. Therefore, the purpose of this study is to assess the safety of 6-months or 12-months maintenance of DAPT in patients undergoing percutaneous coronary intervention (PCI) using Resolute Integrity™ or BioMatrix™ stent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE
  • Drug: 6-month dual anti-platelet therapy
    Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months
    Other Name: Aspirin and Clopidogrel
  • Drug: 12-month dual anti-platelet therapy
    Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months
    Other Name: Aspirin and Clopidogrel
  • Device: Zotarolimus eluting stent
    Zotarolimus eluting stent is applied to coronary stenotic lesion
  • Device: Biolimus eluting stent
    Biolimus eluting stent is applied to coronary stenotic lesion
Study Arms  ICMJE
  • Experimental: 6-month dual anti-platelet therapy
    maintain dual anti-platelet agents for 6 months
    Intervention: Drug: 6-month dual anti-platelet therapy
  • Active Comparator: 12-month dual anti-platelet therapy
    maintain dual anti-platelet agents for 12 months
    Intervention: Drug: 12-month dual anti-platelet therapy
  • Active Comparator: Zotarolimus eluting stent arm
    implant with zotarolimus eluting stent (Resolute Integrity)
    Intervention: Device: Zotarolimus eluting stent
  • Active Comparator: Biolimus eluting stent arm
    implant with biolimus eluting stent (Biomatrix)
    Intervention: Device: Biolimus eluting stent
Publications * Not Provided

*   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: February 14, 2017)
1368
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 7, 2015
Actual Primary Completion Date June 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must be at least 20 years of age.
  2. Subject must have evidence of myocardial ischemia (e.g. stable angina, non-ST elevation acute coronary syndrome, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
  3. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Resolute Integrity or BioMatrix stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

  1. Acute ST elevation myocardial infarction
  2. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, biolimus, contrast media
  3. Clinical conditions requiring systemic immune suppression over 2 weeks or anti-cancer therapy
  4. Prior history of the following presentations: Thromboembolic disease, Stent thrombosis
  5. Pregnant women or women with childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  6. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  7. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  8. Current known current platelet count < 100,000 cells/mm3 or Hgb <10 g/dL.
  9. Non-cardiac co-morbid conditions are present with life expectancy < 1 year or that may result in protocol non-compliance (per site investigator's medical judgment
  10. Patients with left ventricular ejection fraction < 35%
  11. Patients with cardiogenic shock
  12. Creatinine level > 2.4mg/dL
  13. Severe hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 3 times upper normal reference values)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056118
Other Study ID Numbers  ICMJE 3-2011-0054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: If PI and scientific committee approve to share individual participant data to other researchers.
Responsible Party Hyuck moon Kwon, Gangnam Severance Hospital
Study Sponsor  ICMJE Gangnam Severance Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyuck moon Kwon Gangnam Severance Hospital
PRS Account Gangnam Severance Hospital
Verification Date February 2017

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