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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemic Heart Disease | Drug: 6-month dual anti-platelet therapy Drug: 12-month dual anti-platelet therapy Device: Zotarolimus eluting stent Device: Biolimus eluting stent | Phase 4 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 1368 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Optimal Duration of Clopidogrel After Implantation of Second-Generation Drug-Eluting Stents (OPTIMA-C) |
Actual Study Start Date : | May 2, 2011 |
Actual Primary Completion Date : | June 1, 2015 |
Actual Study Completion Date : | September 7, 2015 |

Arm | Intervention/treatment |
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Experimental: 6-month dual anti-platelet therapy
maintain dual anti-platelet agents for 6 months
|
Drug: 6-month dual anti-platelet therapy
Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months
Other Name: Aspirin and Clopidogrel |
Active Comparator: 12-month dual anti-platelet therapy
maintain dual anti-platelet agents for 12 months
|
Drug: 12-month dual anti-platelet therapy
Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months
Other Name: Aspirin and Clopidogrel |
Active Comparator: Zotarolimus eluting stent arm
implant with zotarolimus eluting stent (Resolute Integrity)
|
Device: Zotarolimus eluting stent
Zotarolimus eluting stent is applied to coronary stenotic lesion |
Active Comparator: Biolimus eluting stent arm
implant with biolimus eluting stent (Biomatrix)
|
Device: Biolimus eluting stent
Biolimus eluting stent is applied to coronary stenotic lesion |
- A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR) [ Time Frame: 12 months ]
- 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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): NCT03056118
Principal Investigator: | Hyuck moon Kwon | Gangnam Severance Hospital |
Responsible Party: | Hyuck moon Kwon, Professor, Gangnam Severance Hospital |
ClinicalTrials.gov Identifier: | NCT03056118 |
Other Study ID Numbers: |
3-2011-0054 |
First Posted: | February 17, 2017 Key Record Dates |
Last Update Posted: | February 17, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | If PI and scientific committee approve to share individual participant data to other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
OPTIMA-C |
Heart Diseases Myocardial Ischemia Coronary Artery Disease Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |