NCT05845489 Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)
| NCT ID | NCT05845489 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 11,086 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 11,086 participants in total. It began in 2023-03-22 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hyo-Soo Kim, MD, PhD
STUDY CHAIR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05845489 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05845489 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05845489 currently recruiting?
Yes, NCT05845489 is actively recruiting participants. Contact the research team at hpcrates@gmail.com for enrollment information.
Where is the NCT05845489 trial being conducted?
This trial is being conducted at Seoul, South Korea, Andong, South Korea, Busan, South Korea, Busan, South Korea and 11 additional locations.
Who is sponsoring the NCT05845489 clinical trial?
NCT05845489 is sponsored by Seoul National University Hospital. The principal investigator is Hyo-Soo Kim, MD, PhD at Seoul National University Hospital. The trial plans to enroll 11,086 participants.