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Clinical Trials in South Korea / NCT05845489
Recruiting Phase 4

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)

NCT05845489 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Phase 4
Started
2023-03-22
Last updated
2025-12-31

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Clopidogrel treatment groupNo antiplatelet or anticoagulant group

Clopidogrel treatment group: Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.

No antiplatelet or anticoagulant group: Patients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.

Study summary

The investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.

The trial will test the hypothesis that clopidogrel is beneficial in preventing major adverse cardiovascular and cerebrovascular events (MACCE) in patients with subclinical coronary atherosclerosis identified on imaging.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Major adverse cardiovascular and cerebrovascular events (MACCE) — at 2 years after the last enrollment
    A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack

Trial sites (61)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Other 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

+ 21 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05845489 on ClinicalTrials.gov ↗ ← All trials in South Korea