NCT05320926

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,744 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 84 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Clopidogrel monotherapy	Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.
DRUG	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 ®)

Timeline

• Start date: 2022-07-26
• Primary completion: 2028-07-10
• Completion: 2028-07-10
• First posted: 2022-04-11
• Last updated: 2024-10-22

Locations

1 site across 1 country: South Korea