Comparing Clopidogrel and Aspirin after Stent Implantation for Heart Disease
Official title: Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial
Run by Yonsei University · NCT05320926 · Data updated 2026-11-12
This study is testing whether clopidogrel or aspirin is better for heart disease patients after they have received a stent to see which one helps them avoid complications in the year following their treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 84 Years |
| Sex | All |
| Enrollment | 3744 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | July 26, 2022 |
| Main results expected | July 10, 2028 |
| Study ends | July 10, 2028 |
| Registry record updated | October 22, 2024 |
| Trial ID | NCT05320926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 19 to 84 who have received zotarolimus-eluting Onyx stents for ischemic heart disease.
✕Probably not a fit
Patients over 85 years old, those with acute myocardial infarction, or those with a life expectancy of less than one year may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of clopidogrel monotherapy versus aspirin monotherapy following a short-term dual antiplatelet therapy (DAPT) in patients with ischemic heart disease who have undergone percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. Patients will be randomized to receive either clopidogrel or aspirin after a 1- to 3-month DAPT period, with stratification based on bleeding risk, clinical presentation, and lesion complexity. The primary outcome is the rate of net adverse clinical events (NACE) at 12 months post-PCI. This study aims to determine which antiplatelet agent is more beneficial for patients after short-term DAPT.
Why it matters
Potential benefit: If successful, this study could help identify the most effective antiplatelet therapy for patients after stent implantation, potentially improving patient outcomes.
How similar studies have gone: Previous studies have shown varying results with different antiplatelet therapies, indicating that this approach is relevant but may still yield novel insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Yonsei University Health System, Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Byeong-Keuk Kim — Severance Cardiovascular Hospital, Yonsei University Health System
- Study coordinator: Byeong-Keuk Kim
- Email: kimbk@yuhs.ac
- Phone: 82-2228-8460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.