UMIN-CTR Clinical Trial

Basic information
Public title	Legacy Effects of PCSK9 Inhibitors on Lipid-Rich Vulnerable Coronary Plaque
Acronym	Legacy Effects of PCSK9 Inhibitors
Scientific Title	Legacy Effects of PCSK9 Inhibitors on Lipid-Rich Vulnerable Coronary Plaque
Scientific Title:Acronym	Legacy Effects of PCSK9 Inhibitors
Region	Japan

Condition
Condition	acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aimed to evaluate vulnerable plaque using near-infrared spectroscopy (NIRS) combined with intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in serial observations; before and after administration of Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), and after cessation of PCSK9i.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The maxLCBI4mm were assessed at baseline, 9 months after PCSK9i, and after cessation of PCSK9i (24 months)
Key secondary outcomes	The maxLCBI4mm,laque burden measured by IVUS, FFR, and low-density lipoprotein cholesterol (LDL-C) were assessed at baseline, 9 months after PCSK9i, and after cessation of PCSK9i (24 months)

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	This study included patients with a history of acute coronary syndrome and more than or equal to 50% coronary stenosis, who were administered PCSK9i due to LDL-C levels more than or equal to 70 mg/dl despite the administration of optimized statin therapy
Key exclusion criteria	A pregnancy or inability to provide written informed consent, Participants had already had anti-PCSK9 antibody on admission
Target sample size	7

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Matsuo
Organization	Gifu Heart Center
Division name	Department of Cardiovascular Medicine
Zip code	500-8384
Address	4-14-4 Yabuta-Minami, Gifu, Japan
TEL	058-277-2277
Email	matsuo@heart-center.or.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Omori
Organization	Gifu Heart Center
Division name	Department of Cardiovascular Medicine
Zip code	500-8384
Address	Department of Cardiovascular Medicine
TEL	058-277-2277
Homepage URL
Email	omori@heart-center.or.jp

Sponsor
Institute	Gifu Heart Center
Institute
Department

Funding Source
Organization	NA
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	Gifu Heart Center
Address	4-14-4 Yabuta-Minami, Gifu
Tel	058-277-2277
Email	inada@heart-center.or.jp

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	2020 Year 09 Month 28 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	7
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	2017 Year 05 Month 10 Day
Date of IRB	2020 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 12 Day
Last follow-up date	2020 Year 07 Month 02 Day
Date of closure to data entry	2020 Year 07 Month 02 Day
Date trial data considered complete	2020 Year 07 Month 02 Day
Date analysis concluded

Other

Other related information

We hypothesized that PCSK9i has legacy effects in terms of plaque stabilization after cessation of therapy. The study aimed to evaluate vulnerable plaque using near-infrared spectroscopy (NIRS) combined with intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in serial observations; before and after administration of PCSK9i, and after cessation of PCSK9i. The maximum value of the lipid-core burden index for any 4-mm segment (maxLCBI4mm), plaque burden measured by IVUS, FFR, and LDL-C were assessed at baseline, 9 months, and 24 months

Management information
Registered date	2020 Year 09 Month 28 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047846