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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Jung-Kyu Han, MD, PhD
hpcrates@gmail.com
821026765736
Backup
Doyeon Hwang, MD
cardiol.intv@gmail.com
821074462779
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 9930
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Kangbuk Samsung Hospital, Hallym University Kangnam Sacred Heart Hospital, Hanyang University, Hallym University Medical Center, Keimyung University Dongsan Medical Center, Wonju Severance Christian Hospital
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov