Efficacy and Safety of Clopidogrel for primary prevention in patients with subclinical coronary atherosclerosis identified on imaging

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008319

Enrollment

11086

Registered

2023-03-22

Start date

2023-03-22

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental - Take one Clopidogrel tablet(75mg) once a day. No intervention - Do not take any Antiplatelet, Anticoagulant.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female aged =40 years 2. Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study 3. Without significant coronary artery stenosis (Diameter stenosis >50%), which needs revascularization 4. Agreement to give written informed consent

Exclusion criteria

Exclusion criteria: 1. A history of a diagnosed cardiovascular event (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis>50%, carotid artery intervention) 2. A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy 3. Absolute contraindication or allergy to clopidogrel 4. Patients receiving anticoagulants for other comorbidities 5. A history of Bleeding diathesis, known coagulopathy, major bleeding, BARC class =3, resulting in the stop of antiplatelet agents 6 Planned surgery or intervention which needs to stop antiplatelet agents =1 month 7. Presence of non-cardiac comorbidity with life expectancy = 5 years from randomization 8. Females with childbearing potential or breast-feeding 9. Patients who are thought to be inappropriate for the trial based on physicians’ discretion

Design outcomes

Secondary

Measure	Time frame
The primary endpoint is major adverse cardiovascular and cerebrovascular events (MACCE), a composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack;Net adeverse clinical event;All-cause death;Cardiovascular death;Non-fatal myocardial infarction;Any coronary revascularization;Ischemic stroke or Transient ischemic attack;non-coronary revascularization;Major bleeding events (BARC classification, type 3 or 5);BARC type 2 bleeding events;BARC type 3 bleeding events;BARC type 5 bleeding events	—

Measure

Time frame

The primary endpoint is major adverse cardiovascular and cerebrovascular events (MACCE), a composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack;Net adeverse clinical event;All-cause death;Cardiovascular death;Non-fatal myocardial infarction;Any coronary revascularization;Ischemic stroke or Transient ischemic attack;non-coronary revascularization;Major bleeding events (BARC classification, type 3 or 5);BARC type 2 bleeding events;BARC type 3 bleeding events;BARC type 5 bleeding events

—

Primary

Measure	Time frame
The primary endpoint is major adverse cardiovascular and cerebrovascular events (MACCE), a composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack	—

Countries

Korea, Republic of

Contacts

Public ContactJung-Kyu Han

Seoul National University Hospital

hpcrates@gmail.com+82-2-2072-4870

Outcome results