CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 3,596 target
Drug / intervention
PCSK9 inhibitors and background lipid-modifying therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06863545
NCT06863545N/ARecruitingHigh MomentumUpdated 4mo ago

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

Second Affiliated Hospital, School of Medicine, Zhejiang University·interventional·Posted Mar 7, 2025·Updated Feb 6, 2026

In Brief

A clinical study evaluating PCSK9 inhibitors and background lipid-modifying therapy and Standard lipid-modifying therapy for Coronary Artery Disease and 3 related conditions. Currently recruiting, targeting 3,596 participants across 6 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, South Korea
Collaborators--

Timeline

N/ARecruiting
202520262027202820292030203120322033
First PostedMar 7, 2025
Enrollment StartApr 22, 2025
Primary CompletionApr 1, 2030
Study CompletionApr 1, 2033
TodayJul 1, 2026
Enrollment to primary: 4.9 yearsPosted 1.3 years agoPrimary completion in 3.8 years

Interventions

PCSK9 inhibitors and background lipid-modifying therapydrug

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.

Standard lipid-modifying therapydrug

Patients will receive standard LMT commonly used in clinical practice.