Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents (OPTIMA-C)
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
6-month dual anti-platelet therapy
12-month dual anti-platelet therapy
Zotarolimus eluting stent
Biolimus eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring OPTIMA-C
Eligibility Criteria
Inclusion Criteria:
- Subject must be at least 20 years of age.
- 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).
- 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:
- Acute ST elevation myocardial infarction
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, biolimus, contrast media
- Clinical conditions requiring systemic immune suppression over 2 weeks or anti-cancer therapy
- Prior history of the following presentations: Thromboembolic disease, Stent thrombosis
- 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.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count < 100,000 cells/mm3 or Hgb <10 g/dL.
- 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
- Patients with left ventricular ejection fraction < 35%
- Patients with cardiogenic shock
- Creatinine level > 2.4mg/dL
- Severe hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 3 times upper normal reference values)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
6-month dual anti-platelet therapy
12-month dual anti-platelet therapy
Zotarolimus eluting stent arm
Biolimus eluting stent arm
Arm Description
maintain dual anti-platelet agents for 6 months
maintain dual anti-platelet agents for 12 months
implant with zotarolimus eluting stent (Resolute Integrity)
implant with biolimus eluting stent (Biomatrix)
Outcomes
Primary Outcome Measures
A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR)
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.
MI Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03056118
First Posted
February 8, 2017
Last Updated
February 14, 2017
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03056118
Brief Title
Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents
Acronym
OPTIMA-C
Official Title
Optimal Duration of Clopidogrel After Implantation of Second-Generation Drug-Eluting Stents (OPTIMA-C)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2, 2011 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
September 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
OPTIMA-C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1368 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6-month dual anti-platelet therapy
Arm Type
Experimental
Arm Description
maintain dual anti-platelet agents for 6 months
Arm Title
12-month dual anti-platelet therapy
Arm Type
Active Comparator
Arm Description
maintain dual anti-platelet agents for 12 months
Arm Title
Zotarolimus eluting stent arm
Arm Type
Active Comparator
Arm Description
implant with zotarolimus eluting stent (Resolute Integrity)
Arm Title
Biolimus eluting stent arm
Arm Type
Active Comparator
Arm Description
implant with biolimus eluting stent (Biomatrix)
Intervention Type
Drug
Intervention Name(s)
6-month dual anti-platelet therapy
Other Intervention Name(s)
Aspirin and Clopidogrel
Intervention Description
Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months
Intervention Type
Drug
Intervention Name(s)
12-month dual anti-platelet therapy
Other Intervention Name(s)
Aspirin and Clopidogrel
Intervention Description
Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months
Intervention Type
Device
Intervention Name(s)
Zotarolimus eluting stent
Intervention Description
Zotarolimus eluting stent is applied to coronary stenotic lesion
Intervention Type
Device
Intervention Name(s)
Biolimus eluting stent
Intervention Description
Biolimus eluting stent is applied to coronary stenotic lesion
Primary Outcome Measure Information:
Title
A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR)
Description
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.
MI Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be at least 20 years of age.
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).
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:
Acute ST elevation myocardial infarction
The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, biolimus, contrast media
Clinical conditions requiring systemic immune suppression over 2 weeks or anti-cancer therapy
Prior history of the following presentations: Thromboembolic disease, Stent thrombosis
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.
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Current known current platelet count < 100,000 cells/mm3 or Hgb <10 g/dL.
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
Patients with left ventricular ejection fraction < 35%
Patients with cardiogenic shock
Creatinine level > 2.4mg/dL
Severe hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 3 times upper normal reference values)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuck moon Kwon
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
If PI and scientific committee approve to share individual participant data to other researchers.
Citations:
PubMed Identifier
32588238
Citation
Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.
Results Reference
derived
Learn more about this trial
Optimal Duration of Clopidogrel in Second-Generation Drug-Eluting Stents
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