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

NCT ID: NCT05320926

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2028-07-10

Brief Summary

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

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).

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short-term DAPT followed by clopidogrel monotherapy

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.

Group Type: EXPERIMENTAL

Clopidogrel monotherapy

Intervention Type: DRUG

Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.

zotarolimus-eluting stent (Resolute Onyx ®)

Intervention Type: DEVICE

zotarolimus-eluting stent (Resolute Onyx ®)

Short-term DAPT followed by aspirin monotherapy

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.

Group Type: ACTIVE_COMPARATOR

Aspirin monotherapy

Intervention Type: DRUG

Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.

zotarolimus-eluting stent (Resolute Onyx ®)

Intervention Type: DEVICE

zotarolimus-eluting stent (Resolute Onyx ®)

Interventions

Clopidogrel monotherapy

Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.

Intervention Type: DRUG

Aspirin monotherapy

Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.

Intervention Type: DRUG

zotarolimus-eluting stent (Resolute Onyx ®)

zotarolimus-eluting stent (Resolute Onyx ®)

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byeong-Keuk Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Cardiovascular Hospital, Yonsei University Health System

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Byeong-Keuk Kim

Role: CONTACT

kimbk@yuhs.ac

82-2228-8460

Facility Contacts

Byeong-Keuk Kim

Role: primary

kimbk@yuhs.ac

82-2228-8460

Other Identifiers

4-2022-0050

Identifier Type: -

Identifier Source: org_study_id