UMIN-CTR Clinical Trial

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
Email	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
Email	strsasaki@hotmail.co.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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033179