UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058813 |
|---|---|
| Receipt number | R000067256 |
| Scientific Title | Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies |
| Date of disclosure of the study information | 2025/08/16 |
| Last modified on | 2025/08/16 14:04:40 |
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Basic information
Public title
Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies
Acronym
Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies
Scientific Title
Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies
Scientific Title:Acronym
Plaque Regression and Stabilization by Proprotein convertase subtilisin/kexin type 9 Inhibitors: A Meta-Analysis of Intravascular Imaging Studies
Region
| Japan |
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 specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in percent atheroma volume (PAV), fibrous cap thickness (FCT), and maximum lipid core burden index within 4 mm (maxLCBI4mm) from baseline to follow-up will be evaluated between the PCSK9 inhibitor group and the control group using an inverse variance random-effects meta-analysis.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | 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.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Umezono |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
321-0293
Address
880, Kitakobayashi, Mibumachi, Shimotsugagun, Tochigi, Japan
TEL
0282872146
umezono.akita587@gmail.com
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Umezono |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
321-0293
Address
880, Kitakobayashi, Mibumachi, Shimotsugagun, Tochigi, Japan
TEL
0282872146
Homepage URL
umezono.akita587@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Ryu Umezono
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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.
Management information
Registered date
| 2025 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067256
