UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041925 |
|---|---|
| Receipt number | R000047846 |
| Scientific Title | Legacy Effects of PCSK9 Inhibitors on Lipid-Rich Vulnerable Coronary Plaque |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2020/09/28 20:36:20 |
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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
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
omori@heart-center.or.jp
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047846
