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Clinical Trials in South Korea / NCT05320926
Recruiting Not applicable

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

NCT05320926 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2022-07-26
Last updated
2024-10-22

Condition(s) studied

Ischemic Heart Disease

Investigational drug(s) / intervention(s)

Clopidogrel monotherapy →Aspirin monotherapy →zotarolimus-eluting stent (Resolute Onyx ®)

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
84 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Net adverse clinical events (NACE) — 1 year after the procedure
    Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Other trials for the same condition

Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve Recruiting
Imaging and Physiologic Evaluation of Coronary Artery Disease Recruiting
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Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE) Recruiting
Multicenter Registry of Coronary Flow-Derived Indexes for Coronary Microvascular Disease (Multicenter FLOW-CMD Registry) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05320926 on ClinicalTrials.gov ↗ ← All trials in South Korea