Coronary Heart Disease Clinical Trials

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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject must be ≥ 18 years.

• Patients with at least one target lesion meet CCTA-detected plaque features of the following:

‣ Degree of stenosis ≥ 50% or plaque burden ≥ 70%

⁃ At least 2 of the following high-risk plaque features:

• i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium

• The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.

• Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.

Locations
Other Locations
China
Hangzhou Linping First People's Hospital
RECRUITING
Hangzhou
The Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Zhejiang Hospital
RECRUITING
Hangzhou
Zhejiang Provincial Hospital of Traditional Chinese Medicine
RECRUITING
Hangzhou
Jinhua Central Hospital
RECRUITING
Jinhua
Republic of Korea
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Xinyang Hu
hxy0507@126.com
+86 0571 87784808
Backup
Jian'an Wang
wangjianan111@zju.edu.cn
+86 0571 87784808
Time Frame
Start Date: 2025-04-22
Estimated Completion Date: 2033-04
Participants
Target number of participants: 3596
Treatments
Experimental: PCSK9 inhibitors plus background lipid-modifying therapy
Patients will receive PCSK9 inhibitors treatment and background lipid-modifying therapy for the first 12 months after randomization, and then continue background lipid-modifying therapy for the remainder of the trial.
Active_comparator: Standard lipid-modifying therapy
Patients will receive standard LMT commonly used in clinical practice.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov