UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040318
Receipt No. R000045996
Scientific Title Impact of PCSK9 Inhibitor on the Characteristics of Lipid-rich Coronary Plaques Assessed by Near-infrared Spectroscopy
Date of disclosure of the study information 2020/05/07
Last modified on 2020/05/07

* 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 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


Contact us.