Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clopidogrel monotherapy, Aspirin monotherapy, zotarolimus-eluting stent (Resolute Onyx ®).
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease. Basic parameters: 19 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- 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 ®)
Primary outcome measures
- Net adverse clinical events (NACE) [Time frame: 1 year after the procedure]
Secondary outcome measures (6)
- Each component of NACE [Time frame: 1 year after the procedure]
- Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke) [Time frame: 1 year after the procedure]
- Cardiac death [Time frame: 1 year after the procedure]
- Stent thrombosis (definite or probable) [Time frame: 1 year after the procedure]
- Target-vessel revascularization [Time frame: 1 year after the procedure]
- Target-lesion revascularization [Time frame: 1 year after the procedure]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University Health System, Severance Hospital — Seoul
Identifiers
NCT: NCT05320926 · 4-2022-0050