UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029207 |
|---|---|
| Receipt number | R000033179 |
| Scientific Title | Prospective Observational study for Lesion of neoatherosclerosis; the efficacy of Alirocumab for the neoatherosclerosis Reaction Investigated by Serial optical coherence tomography |
| Date of disclosure of the study information | 2017/09/21 |
| Last modified on | 2021/09/23 19:25:33 |
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Basic information
Public title
Prospective Observational study for Lesion of neoatherosclerosis; the efficacy of Alirocumab for the neoatherosclerosis Reaction Investigated by Serial optical coherence tomography
Acronym
POLARIS study
Scientific Title
Prospective Observational study for Lesion of neoatherosclerosis; the efficacy of Alirocumab for the neoatherosclerosis Reaction Investigated by Serial optical coherence tomography
Scientific Title:Acronym
POLARIS study
Region
| Japan |
Condition
Condition
neoatherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the efficacy of alirocumab for neoatherosclerosis in second-generation drug eluting stent by serial optical coherence tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploratory research for the findings of optical coherence tomography after nine months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The age at the time of consent acquisition is 20 years old or over.
(2) OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
(3) lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
(4) Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
(5) Document consent has been obtained from the subject person to this research.
Key exclusion criteria
(1) Patients who have received treatment with PCSK 9 inhibitor in the past
(2) Patients whose treatment was interrupted before follow-up catheterization during the observation period
(3) Patients underwent LDL apheresis.
(4) In the case that the researchers judges it as inappropriate as the object of this research.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Sasaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan
TEL
078-382-5846
Homepage URL
strsasaki@hotmail.co.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine.
Division of Cardiovascular Medicine, Department of Internal Medicine.
Institute
Department
Personal name
Funding Source
Organization
none
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
the institutional review board of Kobe University Hospital
Address
Kobe University Graduate School of Medicine 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo,
Tel
078-382-6669
kansatsu@med.kobe-u.ac.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
| 2017 | Year | 09 | Month | 21 | 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
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
nothing particular
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033179
