Using clopidogrel to prevent heart issues in patients with early signs of coronary artery disease
Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
PHASE4 · Seoul National University Hospital · NCT05845489
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 11086 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 61 sites (Seoul, Other and 60 other locations) |
| Trial ID | NCT05845489 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with subclinical coronary atherosclerosis identified through imaging, without significant coronary artery stenosis requiring revascularization.
Not a fit: Patients with a history of cardiovascular or cerebrovascular diseases or those requiring chronic antiplatelet therapy will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul, Other and 60 other locations
- 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)
- 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
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: Coronary Artery Disease, coronary artery disease, clopidogrel, prevention