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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05845489

Collaborator

Hallym University Kangnam Sacred Heart Hospital (Other), Hallym University Medical Center (Other), Hanyang University (Other), Keimyung University Dongsan Medical Center (Other), Kangbuk Samsung Hospital (Other), Wonju Severance Christian Hospital (Other)

9,930

Enrollment

Location

Arms

84.7

Anticipated Duration (Months)

117.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Clopidogrel treatment group Other: No antiplatelet or anticoagulant group	Phase 4

Detailed Description

Coronary artery disease (CAD) is the most prevalent and lethal disease worldwide. Even though various studies have been performed regarding the prevention or treatment of CAD and its related cardiovascular events, the prevalence of CAD and the incidence of cardiovascular events are increasing.

Antiplatelet agents are among the most widely used drugs for preventing cardiovascular events. The efficacy of antiplatelet agents has been extensively proven in secondary prevention for cardiovascular events in CAD patients, and their use has been recommended in current guidelines. However, there is still controversy surrounding the prescription of antiplatelet agents for the primary prevention of cardiovascular events in CAD patients due to their unknown clear efficacy and risk of bleeding complications.

Recent studies reported the limited efficacy of aspirin in old patients, diabetes patients, or patients with cardiovascular events risks. However, the efficacy or safety of antiplatelet therapy in patients with subclinical coronary atherosclerosis has not been thoroughly investigated. These patients are at higher risk of cardiac death or myocardial infarction compared to patients without coronary atherosclerosis.

In this regard, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9930 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging

Actual Study Start Date :

Mar 9, 2023

Anticipated Primary Completion Date :

Mar 31, 2030

Anticipated Study Completion Date :

Mar 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clopidogrel treatment group Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.	Drug: Clopidogrel treatment group Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: Clopidogrel treatment group

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

Drug: Clopidogrel treatment group

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

Active Comparator: 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.

Other: No antiplatelet or anticoagulant group

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular and cerebrovascular events (MACCE) [5 years after randomization]
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack

Secondary Outcome Measures

Major adverse cardiovascular and cerebrovascular events (MACCE) in men [5 years after randomization]
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack
Major adverse cardiovascular and cerebrovascular events (MACCE) in women [5 years after randomization]
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack
Net adverse clinical event [5 years after randomization]
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke or transient ischemic attack, major bleeding
All-cause death [5 years after randomization]
Non-fatal myocardial infarction [5 years after randomization]
Any coronary revascularization [5 years after randomization]
Ischemic stroke or Transient ischemic attack [5 years after randomization]
Any non-coronary revascularization [5 years after randomization]
Major bleeding events [5 years after randomization]
BARC classification, type 3 or 5
BARC type 2 bleeding events [5 years after randomization]
BARC type 3 bleeding events [5 years after randomization]
BARC type 5 bleeding events [5 years after randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 (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