UMIN-CTR Clinical Trial

Basic information
Public title	Pemafibrate for prevention of atherosclerotic diseases in patients with ischemic stroke or transient ischemic attack
Acronym	Pemafibrate in stroke patients
Scientific Title	Pemafibrate for prevention of atherosclerotic diseases in patients with stroke or transient ischemic attack
Scientific Title:Acronym	Pemafibrate for prevention of atherosclerotic diseases in stroke patients (PPAR-Stroke)
Region	Japan

Condition
Condition	ischemic stroke, transient ischemic attack
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of pemafibrate for carotid atherosclerosis and vascular risk after ischemic stroke or transient ischemic attack
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Carotid intima media thickness
Key secondary outcomes	1. Major cardiovascular events (nonfatal stroke, nonfatal coronary artery disease, nonfatal peripheral artery disease, and vascular death) and all cause death 2. Lipid and glucose metabolites and inflammatory markers in blood samples 3. Brain magnetic resonance imaging and angiography findings 4. New onset of dementia 5. New onset of atrial fibrillation

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	Patients with ischemic stroke or transient ischemic attack who started to receive pemafibrate for atherogenic dyslipidemia. Statin therapy is prioritized if the patient has hyper LDL cholesterolemia.
Key exclusion criteria	1. Contraindications for pemafibrate (e.g., allergy to the drug, severe kidney dysfunction, pregnancy etc.) 2. Patients who have a history of or plan to undergo carotid endarterectomy/carotid stenting 3. Patients who had received pemafibrate before index event
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Kitagawa
Organization	Tokyo Women's Medical University
Division name	Department of Neurology
Zip code	1628666
Address	Kawada-cho, Shinjuku-ku
TEL	0333538111
Email	kitagawa.kazuo@twmu.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Hoshino
Organization	Tokyo Women's Medical University
Division name	Department of Neurology
Zip code	1628666
Address	Kawada-cho, Shinjuku-ku, Tokyo
TEL	0333538111
Homepage URL
Email	hoshino.takao@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Women's Medical University IRB
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel	0333538111
Email	Krinri.bm@twmu.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	2020 Year 06 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 24 Day
Date of IRB	2019 Year 09 Month 24 Day
Anticipated trial start date	2019 Year 09 Month 24 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 06 Month 01 Day
Last modified on	2020 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046346

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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