Using clopidogrel to prevent heart issues in patients with early signs of coronary artery disease
Official title: Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
Run by Seoul National University Hospital · NCT05845489 · Data updated 2026-11-12
This study is testing if the medication clopidogrel can help prevent heart problems in people who have early signs of coronary artery disease but don't need surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 11086 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 61 sites (Seoul, Other and 60 other locations) |
| Status | Recruiting |
| Started | March 22, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2031 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT05845489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 and older with subclinical coronary atherosclerosis identified through imaging, without significant coronary artery stenosis requiring revascularization.
✕Probably not a fit
Patients with a history of cardiovascular or cerebrovascular diseases or those requiring chronic antiplatelet therapy will 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 evaluates the effectiveness and safety of clopidogrel as a preventive treatment for patients with subclinical coronary atherosclerosis who do not require revascularization. The study aims to determine if clopidogrel can reduce the risk of major adverse cardiovascular and cerebrovascular events in these patients. Participants will be randomly assigned to receive either clopidogrel or no antiplatelet therapy, allowing for a comparison of outcomes. The trial addresses a gap in current knowledge regarding primary prevention strategies for coronary artery disease.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of cardiovascular events due to subclinical coronary atherosclerosis.
How similar studies have gone: While antiplatelet therapy has been established for secondary prevention, the use of clopidogrel for primary prevention in patients with subclinical coronary atherosclerosis is a novel approach that has not been thoroughly tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged ≥40 years * Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study * Without significant coronary artery stenosis (Diameter stenosis \>50%), which needs revascularization * Agreement to give written informed consent Exclusion Criteria: * A history of a diagnosed cardiovascular or cerebrovascular disease (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis\>50%, carotid artery intervention) * A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy * Absolute contraindication or allergy to clopidogrel * Patients receiving anticoagulants for other comorbidities * A history of Bleeding diathesis, known coagulopathy, or major bleeding, BARC class ≥3, resulting in the stop of antiplatelet agents * Planned surgery or intervention which needs to stop antiplatelet agents ≥1 month * Presence of non-cardiac comorbidity with life expectancy ≤ 5 years at randomization * Females with pregnancy or breast-feeding * Patients who are thought to be inappropriate for the trial based on physicians' decision
Where it's running
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Seoul National University Hospital
Seoul, Other, South Korea Recruiting -
Andong Hospital
Andong, South Korea Recruiting -
Dong-A University Hospital
Busan, South Korea Recruiting -
Inje University Busan Paik Hospital
Busan, South Korea Recruiting -
Kosin University Gospel Hospital
Busan, South Korea Recruiting -
Pusan National University Hospital
Busan, South Korea Recruiting
Show 44 more locations
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Gyeongsang National University Changwon Hospital
Changwon, South Korea Recruiting -
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea Recruiting -
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea Recruiting -
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea Recruiting -
Chungbuk National University Hospital
Cheongju-si, South Korea Recruiting -
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea Recruiting -
Kangwon National University Hospital
Chuncheon, South Korea Recruiting -
Kangwon National University Hospital
Chuncheon, South Korea Recruiting -
Keimyung University Dongsan Hospital
Daegu, South Korea Recruiting -
Yeungnam University Medical Center
Daegu, South Korea Recruiting -
Chungnam National University Hospital
Daejeon, South Korea Recruiting -
Eulji University Hospital, Daejeon
Daejeon, South Korea Recruiting -
Gangneung Asan Hospital
Gangneung, South Korea Recruiting -
Chonnam National University Hospital
Gwangju, South Korea Recruiting -
Chonnam National University Hospital
Gwangju, South Korea Recruiting -
Kwangju Christian Hospital
Gwangju, South Korea Recruiting -
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, South Korea Recruiting -
Eulji University Hospital, Uijeongbu
Gyeonggi-do, South Korea Recruiting -
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea Recruiting -
Hallym University Sacred Heart Hospital
Gyeonggi-do, South Korea Recruiting -
Inje University Ilsan Paik Hospital
Gyeonggi-do, South Korea Recruiting -
Myongji Hospital
Gyeonggi-do, South Korea Recruiting -
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, South Korea Recruiting -
Sejong General Hospital, Bucheon
Gyeonggi-do, South Korea Recruiting -
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, South Korea Recruiting -
Yonsei University Yongin Severance Hospital
Gyeonggi-do, South Korea Recruiting -
Chonnam National University Hwasun Hospital
Hwasun, South Korea Recruiting -
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea Recruiting -
Gachon University Gil Medical Center
Incheon, South Korea Recruiting -
Jeju National University Hospital
Jeju City, South Korea Recruiting -
Jesus Hospital, Jeonju
Jeonju, South Korea Recruiting -
Gyeongsang National University Hospital
Jinju, South Korea Recruiting -
Pohang Stroke And Spine Hospital
Pohang, South Korea Recruiting -
Chungnam National University Sejong Hospital
Sejong, South Korea Recruiting -
Chung-Ang University Hospital
Seoul, South Korea Recruiting -
Chung-Ang University Hospital
Seoul, South Korea Recruiting -
Ewha Womans University Seoul Hospital
Seoul, South Korea Recruiting -
Ewha Womans University Seoul Hospital
Seoul, South Korea Recruiting -
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea Recruiting -
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea Recruiting -
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea Recruiting -
Hanyang University Hospital
Seoul, South Korea Recruiting -
Inje University Sanggye Paik Hospital
Seoul, South Korea Recruiting -
Kangbuk Samsung Hospital
Seoul, South Korea Recruiting
+11 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Jung-Kyu Han, MD, PhD
- Email: hpcrates@gmail.com
- Phone: 821026765736
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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.