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
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
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
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
