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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029207
Receipt No. 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 2018/11/06

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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
Middle name
Last name Hiromasa Otake
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan
TEL 078-382-5846
Email hotake@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Sugizaki
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan
TEL 078-382-5846
Homepage URL
Email you0724@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine.
Division of Cardiovascular Medicine, Department of Internal Medicine.
Institute
Department

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
Address
Tel
Email

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
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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