UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040619 |
|---|---|
| Receipt number | R000046346 |
| Scientific Title | Pemafibrate for prevention of atherosclerotic diseases in patients with stroke or transient ischemic attack |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/04/02 19:11:30 |
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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
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
hoshino.takao@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Partially published
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
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
