UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041269 |
|---|---|
| Receipt number | R000047133 |
| Scientific Title | Comparison of physiological parameter on vulnerable plaque between PCSK9 inhibitors and statin |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2021/09/09 15:17:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of physiological parameter on vulnerable plaque between PCSK9 inhibitors and statin
Acronym
Comparison on vulnerable plaque between PCSK9 inhibitors and statin
Scientific Title
Comparison of physiological parameter on vulnerable plaque between PCSK9 inhibitors and statin
Scientific Title:Acronym
Comparison on vulnerable plaque between PCSK9 inhibitors and statin
Region
| Japan |
Condition
Condition
coronary artery diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the difference of fractional flow reserve (FFR), coronary flow reserve (CFR), index of microcirculatory resistance (IMR)and maxLCBI4mm using near-infrared spectroscopy (NIRS) combined with intravascular ultrasound (IVUS) between PCSK9 inhibitors and statins at baseline and 1 year
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of index of microcirculatory resistance between PCSK9 inhibitors and statins at baseline and 1 year
Key secondary outcomes
Comparison of FFR,CFR,maxLCBI4mm between PCSK9 inhibitors and statins at baseline and 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group which was administrated PCSK9 inhibitors for 1 year (PCSK9i group)
Interventions/Control_2
The group which was administrated statin (statin group)
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
Patiens with coronary artery diseases,a serum LDL-C level more than 70mg/dl, age more than 20, participants have a statin
Key exclusion criteria
A pregnancy or inability to provide written informed consent, Participants had already had anti-PCSK9 antibody on admission
Target sample size
200
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
岐阜ハートセンター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 31 | 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
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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047133
