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

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0008319

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 9930

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

1.A history of a diagnosed cardiovascular event (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
6Planned 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
MACCE in men; MACCE in women;Net adeverse clinical event;All-cause death;Cardiovascular death;Non-fatal myocardial infarction;Any coronary revascularization;Ischemic stroke or Transient ischemic attack;Major bleeding events (BARC classification, type 3 or 5);BARC type 2 bleeding events;BARC type 3 bleeding events;BARC type 5 bleeding events;non-coronary revascularization