Coronary Artery Disease
Conditions
Keywords
coronary artery disease, clopidogrel, 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.
Interventions
DRUGClopidogrel treatment group
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
OTHERNo 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.
Sponsors
Samjin Pharmaceutical Co., Ltd.
CKD Pharmaceutical Limited
Hanmi Pharmaceutical co., ltd.
Yuhan Pharmaceutical Company
Daewoong Pharmaceutical Co. LTD.
Dong-A ST Co., Ltd.
IlDong Pharmaceutical Co Ltd
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 (Type1 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular events (MACCE) | at 2 years after the last enrollment | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical event | at 2 years and 5 years after the last enrollment | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke or transient ischemic attack, major bleeding |
| All-cause death | at 2 years and 5 years after the last enrollment | — |
| Non-fatal myocardial infarction | at 2 years and 5 years after the last enrollment | — |
| Any coronary revascularization | at 2 years and 5 years after the last enrollment | — |
| Ischemic stroke or Transient ischemic attack | at 2 years and 5 years after the last enrollment | — |
| Major adverse cardiovascular and cerebrovascular events (MACCE) | at 5 years after the last enrollment | A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack |
| Major bleeding events | at 2 years and 5 years after the last enrollment | BARC classification, type 3 or 5 |
| BARC type 2 bleeding events | at 2 years and 5 years after the last enrollment | — |
| BARC type 3 bleeding events | at 2 years and 5 years after the last enrollment | — |
| BARC type 5 bleeding events | at 2 years and 5 years after the last enrollment | — |
| Any non-coronary revascularization | at 2 years and 5 years after the last enrollment | — |
Countries
South Korea
Contacts
Primary ContactJung-Kyu Han, MD, PhD
Outcome results
None listed