Tokyo, Aug. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058813) titled 'Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies' on Aug. 16.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Dokkyo Medical University

Condition: Condition - coronary artery disease (CAD) or acute coronary syndrome (ACS), including unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effects of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors on the structure and composition of coronary plaques by conducting a meta-analysis using data from three intravascular imaging modalities, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near-infrared spectroscopy (NIRS), and to comprehensively assess their effects on plaque regression and stabilization. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Eligible studies included adult patients with CAD or ACS (UA, NSTEMI, STEMI). Study designs were randomized controlled trials, prospective cohort studies, or retrospective observational studies. The intervention group received PCSK9 inhibitors in addition to statin therapy, and the control group received statin monotherapy or statin plus placebo. Studies were required to assess coronary plaque characteristics at both baseline and follow-up using intravascular imaging modalities (IVUS, OCT, or NIRS). Studies without imaging evaluation or without sufficient data for quantitative synthesis were excluded. Key exclusion criteria - Eligible studies included adult patients with CAD or ACS (UA, NSTEMI, STEMI). Study designs were randomized controlled trials, prospective cohort studies, or retrospective observational studies. The intervention group received PCSK9 inhibitors in addition to statin therapy, and the control group received statin monotherapy or statin plus placebo. Studies were required to assess coronary plaque characteristics at both baseline and follow-up using intravascular imaging modalities (IVUS, OCT, or NIRS). Studies without imaging evaluation or without sufficient data for quantitative synthesis were excluded.

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 06 Month 29 Day Date of IRB - 2025 Year 06 Month 29 Day Anticipated trial start date - 2025 Year 06 Month 29 Day Last follow-up date - 2025 Year 07 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067256

Disclaimer: Curated by HT Syndication.