Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography

NARecruitingINTERVENTIONAL
Enrollment

3,596

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2033

Conditions
Coronary Artery DiseaseCT AngiographyPCSK9Cardiovascular Events
Interventions
DRUG

PCSK9 inhibitors and background lipid-modifying therapy

Patients will receive subcutaneous injections of PCSK9 inhibitors and oral administration of background LMT (including statins and/or cholesterol absorption inhibitors) for the first 12 months after randomization, with PCSK9 inhibitors administered every 2 weeks. After the first 12 months, patients will discontinue the PCSK9 inhibitors but continue background LMT for the remainder of the trial.

DRUG

Placebo plus background lipid-modifying therapy

Patients will receive subcutaneous injections of placebo and oral administration of background LMT (including statins and/or cholesterol absorption inhibitors) for the first 12 months after randomization, with placebo administered every 2 weeks. After the first 12 months, patients will discontinue the placebo but continue background LMT for the remainder of the trial.

Trial Locations (2)

Unknown

RECRUITING

The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou

NOT_YET_RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER