UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037279
Receipt number R000040190
Scientific Title Long-term serial assessment of neointima by coronary angioscopy and NIRS-IVUS following treatment of PCSK9 inhibitor (DESNOTE-R study)
Date of disclosure of the study information 2019/07/05
Last modified on 2023/12/18 13:45:15

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Basic information

Public title

Long-term serial assessment of neointima by coronary angioscopy and NIRS-IVUS following treatment of PCSK9 inhibitor (DESNOTE-R study)

Acronym

DESNOTE Revive (DESNOTE-R)

Scientific Title

Long-term serial assessment of neointima by coronary angioscopy and NIRS-IVUS following treatment of PCSK9 inhibitor (DESNOTE-R study)

Scientific Title:Acronym

DESNOTE-Revive (DESNOTE-R)

Region

Japan


Condition

Condition

coronary heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the serial change of the plaque morphology after indication of PCSK9 inhibitor.

Basic objectives2

Others

Basic objectives -Others

Plaque assessment on IVUS, OCT, and CAS.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Very late stent failure defined as 1) cardiac death, 2) myocardial infarction or unstable angina due to the target stent, or 3) target lesion revascularization. Cardiac death was defined as the death without known non-cardiac cause.

Key secondary outcomes



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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients in the DESNOTE study in whom LDL cholesterol is insufficiently controlled.

Key exclusion criteria

Patients who is thought to be inappropriate for PCSK9 inhibitor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshiharu
Middle name
Last name Higuchi

Organization

Osaka Police Hospital

Division name

Cardiovascular Division

Zip code

5430035

Address

10-31 Kitayama-cho, Tennoji-ku, Osaka

TEL

06-6771-6051

Email

yhiguchi-ja@umin.net


Public contact

Name of contact person

1st name Yohei
Middle name
Last name Sotomi

Organization

Osaka Police Hospital

Division name

Cardiovascular Division

Zip code

5430035

Address

10-31 Kitayama-cho, Tennoji-ku, Osaka

TEL

06-6771-6051

Homepage URL


Email

sotomiyohei@gmail.com


Sponsor or person

Institute

Osaka Police Hospital

Institute

Department

Personal name



Funding Source

Organization

No

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

IRB, Osaka Police Hospital

Address

10-31 Kitayama-cho, Tennoji-ku, Osaka

Tel

06-6771-6051

Email

yhiguchi-ja@umin.net


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

2019 Year 07 Month 05 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

2019 Year 01 Month 29 Day

Date of IRB

2019 Year 04 Month 03 Day

Anticipated trial start date

2019 Year 04 Month 03 Day

Last follow-up date

2024 Year 04 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no


Management information

Registered date

2019 Year 07 Month 05 Day

Last modified on

2023 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040190


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name