Clinical trial NCT05845489: Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- CloPidogREl for Primary preVENTION (HOST-PREVENTION)
Official title: Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
clopidogrel
prevention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Kangnam Sacred Heart Hospital
name: Hallym University Medical Center
name: Hanyang University
name: Keimyung University Dongsan Medical Center
name: Kangbuk Samsung Hospital
name: Wonju Severance Christian Hospital
First posted: 2023-05-06
Enrollment: 9930
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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 (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

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 5 years after randomization
Secondary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACCE) in men
timeFrame: 5 years after randomization
measure: Major adverse cardiovascular and cerebrovascular events (MACCE) in women
timeFrame: 5 years after randomization
measure: Net adverse clinical event
timeFrame: 5 years after randomization
measure: All-cause death
timeFrame: 5 years after randomization
measure: Non-fatal myocardial infarction
timeFrame: 5 years after randomization
measure: Any coronary revascularization
timeFrame: 5 years after randomization
measure: Ischemic stroke or Transient ischemic attack
timeFrame: 5 years after randomization
measure: Any non-coronary revascularization
timeFrame: 5 years after randomization
measure: Major bleeding events
timeFrame: 5 years after randomization
measure: BARC type 2 bleeding events
timeFrame: 5 years after randomization
measure: BARC type 3 bleeding events
timeFrame: 5 years after randomization
measure: BARC type 5 bleeding events
timeFrame: 5 years after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Other
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD, PhD
role: STUDY_CHAIR
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