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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Drug: Clopidogrel monotherapy; Device: zotarolimus-eluting stent (Resolute Onyx ®); Drug: Aspirin monotherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 3744
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Byeong-Keuk Kim; Phone Number: 82-2228-8460; Email: kimbk@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Byeong-Keuk Kim; Phone Number: 82-2228-8460; Email: kimbk@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Clopidogrel monotherapy; Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.; Device: zotarolimus-eluting stent (Resolute Onyx ®); zotarolimus-eluting stent (Resolute Onyx ®)
Active Comparator: 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.	Device: zotarolimus-eluting stent (Resolute Onyx ®); zotarolimus-eluting stent (Resolute Onyx ®); Drug: Aspirin monotherapy; Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Byeong-Keuk Kim, Severance Cardiovascular Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 10, 2028

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Aspirin
• Other Study ID Numbers: 4-2022-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No