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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel treatment group
* Other: No antiplatelet or anticoagulant group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel treatment group<br>Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years. | Drug: Clopidogrel treatment group<br>* Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.<br>|
| Active Comparator: No antiplatelet or anticoagulant group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular and cerebrovascular events (MACCE) in men | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack | 5 years after randomization | 
| Major adverse cardiovascular and cerebrovascular events (MACCE) in women | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack | 5 years after randomization | 
| Net adverse clinical event | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke or transient ischemic attack, major bleeding | 5 years after randomization | 
| 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 | BARC classification, type 3 or 5 | 5 years after randomization | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, clopidogrel, prevention