Comparing Clopidogrel and Aspirin after Stent Implantation for Heart Disease
Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial
NA · Yonsei University · NCT05320926
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3744 (estimated) |
| Ages | 19 Years to 84 Years |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05320926 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19 to 84 who have received zotarolimus-eluting Onyx stents for ischemic heart disease.
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.
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 performed: Previous studies have shown varying results with different antiplatelet therapies, indicating that this approach is relevant but may still yield novel insights.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Heart Disease