UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040318
Receipt number 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 13:04:10

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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 or person

Institute

Gifu Heart Center

Institute

Department

Personal name



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

Value
https://center6.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