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NCT Number: NCT05320926

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.

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Key information

Age range

19 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Byeong-Keuk Kim

CONTACT

[email protected]

82-2228-8460

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age ≥ 85 years
  • Acute myocardial infarction
  • 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

Treatment and study plan

Clopidogrel monotherapy

Drug

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

Aspirin monotherapy

Drug

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

zotarolimus-eluting stent (Resolute Onyx ®)

Device

zotarolimus-eluting stent (Resolute Onyx ®)

Primary outcomes

  1. Net adverse clinical events (NACE)

    Time frame: 1 year after the procedure

    Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)

Secondary outcomes

  1. Each component of NACE

    Time frame: 1 year after the procedure

  2. Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke)

    Time frame: 1 year after the procedure

  3. Cardiac death

    Time frame: 1 year after the procedure

  4. Stent thrombosis (definite or probable)

    Time frame: 1 year after the procedure

  5. Target-vessel revascularization

    Time frame: 1 year after the procedure

  6. Target-lesion revascularization

    Time frame: 1 year after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Byeong-Keuk Kim

CONTACT

[email protected]

82-2228-8460

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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