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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320926
• Other study ID #: 4-2022-0050
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: July 10, 2025

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Byeong-Keuk Kim
• Phone: 82-2228-8460
• Email: kimbk[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3744
• Est. completion date: July 10, 2025
• Est. primary completion date: July 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel monotherapy
Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.
• Aspirin monotherapy
Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.

Device:
• zotarolimus-eluting stent (Resolute Onyx ®)
zotarolimus-eluting stent (Resolute Onyx ®)

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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