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

Yonsei University

Status: Enrolling

Conditions: Ischemic Heart Disease

Treatments: Drug: Clopidogrel monotherapy; Device: zotarolimus-eluting stent (Resolute Onyx ®); Drug: Aspirin monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05320926

4-2022-0050

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 3,744 estimated patients

Sex: All

Ages: 19 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥19 years
2. Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
3. Provision of informed consent

Exclusion criteria

1. Age ≥ 85 years

2. Acute myocardial infarction

3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,744 participants in 2 patient groups

Short-term DAPT followed by clopidogrel monotherapy

Experimental group

Description:

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.

Treatment:

Device: zotarolimus-eluting stent (Resolute Onyx ®)

Drug: Clopidogrel monotherapy

Short-term DAPT followed by aspirin monotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin monotherapy

Device: zotarolimus-eluting stent (Resolute Onyx ®)