UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027238 |
|---|---|
| Receipt number | R000031206 |
| Scientific Title | Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound |
| Date of disclosure of the study information | 2017/05/03 |
| Last modified on | 2017/05/03 16:08:46 |
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Basic information
Public title
Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound
Acronym
Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound
Scientific Title
Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound
Scientific Title:Acronym
Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound
Region
| Japan |
Condition
Condition
coronary disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis for regression of atherosclerosis in acute coronary syndrome patients after PCSK9 inhibitor therapy by using near-infrared spectroscopy and intravascular ultrasound
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The stenosis degree and the levels of lipid core burden index in the lesion which is different form culprit lesion after six months PCSK9 inhibitor therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using PCSK9 inhibitor therapy for acute coronary syndrome patients
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
Acute coronary syndrome patients with the lesion which is different form culprit lesion
Key exclusion criteria
Patients with intolerance to PCSK9 inhibitor, intolerance to anti-coagulant and anti-platelet therapy, not crossing the NIRS-IVUS, severe complication (severe liver dysfunction, severe renal failure, uncontrolled hypertension), and unstable hemodynamics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoaki Matoba |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiology
Zip code
Address
465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ward Kyoto 602-8566, Japan
TEL
075-251-5511
matoba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Wakana |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiology
Zip code
Address
465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ward Kyoto 602-8566, Japan
TEL
075-251-5511
Homepage URL
nw0920@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Address
Tel
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
| 2017 | Year | 05 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031206
