UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047133