Comparing two types of stents for heart patients on short-term medication
Official title: Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
Run by Yonsei University · NCT05305482 · Data updated 2026-11-12
This study is testing whether a new type of heart stent without a polymer works better than a biodegradable one for patients with acute coronary syndrome who are on short-term medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 3520 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | August 10, 2022 |
| Main results expected | February 14, 2030 |
| Study ends | February 14, 2030 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT05305482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 19 and older who are suitable for treatment with either type of stent due to acute coronary syndrome.
✕Probably not a fit
Patients who are pregnant, require oral anticoagulation therapy, or cannot be followed for one year post-enrollment 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 trial aims to evaluate the effectiveness of a polymer-free drug-coated stent (DCS) compared to a biodegradable polymer drug-eluting stent (DES) in patients with acute coronary syndrome (ACS) who will undergo percutaneous coronary intervention. Participants will be randomly assigned to receive either the DCS or DES, followed by one month of dual-antiplatelet therapy (DAPT) with ticagrelor and aspirin, after which they will continue with ticagrelor monotherapy for 11 months. The primary outcome will be assessed through a composite of all-cause mortality, myocardial infarction, or revascularization within one year. This open-label, multi-center study will provide insights into the safety and efficacy of these stent types in a real-world clinical setting.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with acute coronary syndrome, potentially reducing complications and enhancing recovery.
How similar studies have gone: Previous studies have shown promising results with drug-coated and drug-eluting stents, but this specific comparison in the context of one-month DAPT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥19 years 2. All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome 3. Provision of informed consent Exclusion Criteria: 1. Current or potential pregnancy 2. Need of oral anticoagulation therapy 3. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Where it's running
-
Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Chul-Min Ahn — Yonsei University Health System, Severance Hospital
- Study coordinator: Chul-Min Ahn
- Email: drcello@yuhs.ac
- Phone: +82-2-2228-8532
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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.