UMIN-CTR Clinical Trial

Basic information
Public title	Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy
Acronym	Impact of PCSK9 Inhibitor on Lipid-rich Plaque
Scientific Title	Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy
Scientific Title:Acronym	Impact of PCSK9 Inhibitor on Lipid-rich Plaque
Region	Japan

Condition
Condition	Ischemic Heart Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of PCSK9i on coronary plaque components in patients with a history of CAD using near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare administration of PCSK9i with statin-medication on coronary plaque components in patients with CAD using gray-scale- and NIRS- derived measurement
Key secondary outcomes	To compare administration of PCSK9i with statin-medication on biomarker profiles

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had received CAG and NIRS-IVUS for ACS or chronic coronary syndrome (CCS). Patients were required to have been treated with stable LLTs (including no drug medication) for at least 4 weeks before enrollment into the present study and to have an LDL-C level of more than 80 mg/dl at baseline NIRS-IVUS.
Key exclusion criteria	(i) Patients with ST-elevated myocardial infarction (ii) Chronic renal disease manifested by estimated glomerular filtration rate of less than 40 ml/min/1.73 m2 (iii) Any clinically significant abnormality identified at screening visit, physical examination, laboratory tests, or comorbidities, which, in the judgment of the investigator, would preclude safe completion of the study (to continue LLTs or perform a follow-up NIRS-IVUS).
Target sample size	50

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

Public contact
Name of contact person	1st name Hideaki Middle name Last name Ota
Organization	Gifu Heart Center
Division name	Department of Cardiology
Zip code	500-8384
Address	4-14-4 Yabuta-minami, Gifu-city, Gifu
TEL	058-277-2277
Homepage URL
Email	ota@heart-center.or.jp

Sponsor
Institute	Gifu Heart Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Gifu Heart Center
Address	4-14-4 Yabuta-minami, Gifu-city, Gifu,
Tel	058-277-2277
Email	hide-o-5217@live.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 05 Month 07 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	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 15 Day
Date of IRB	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The enrolled patients received LLT according to the latest guideline of American Heart Association/American College of Cardiology after baseline NIRS-IVUS, and the patients were allocated to two groups, namely statin-treated and PCSK9i-administered groups.

Management information
Registered date	2020 Year 05 Month 07 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045996

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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