Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Study Overview
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Brief Summary
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Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.

Detailed Description
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The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows: If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity. In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion).

Official Title
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Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Drug: Clopidogrel monotherapy
* Drug: Aspirin monotherapy
* Device: zotarolimus-eluting stent (Resolute Onyx ®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥19 years Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease Provision of informed consent Exclusion Criteria: Age ≥ 85 years Acute myocardial infarction 2. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy < 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short-term DAPT followed by clopidogrel monotherapy<br>atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT. | Drug: Clopidogrel monotherapy<br>* Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.<br>Device: zotarolimus-eluting stent (Resolute Onyx ®)<br>* zotarolimus-eluting stent (Resolute Onyx ®)<br>|
| Active Comparator: Short-term DAPT followed by aspirin monotherapy<br>Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT. | Drug: Aspirin monotherapy<br>* Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.<br>Device: zotarolimus-eluting stent (Resolute Onyx ®)<br>* zotarolimus-eluting stent (Resolute Onyx ®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical events (NACE) | Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5) | 1 year after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each component of NACE |  | 1 year after the procedure | 
| Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke) |  | 1 year after the procedure | 
| Cardiac death |  | 1 year after the procedure | 
| Stent thrombosis (definite or probable) |  | 1 year after the procedure | 
| Target-vessel revascularization |  | 1 year after the procedure | 
| Target-lesion revascularization |  | 1 year after the procedure |