UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061332 |
|---|---|
| Receipt number | R000070177 |
| Scientific Title | Factor XIa Inhibitors for Secondary Prevention After Ischemic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Clinical Trials |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/06/28 12:01:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Factor XIa Inhibitors for Secondary Prevention After Ischemic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Clinical Trials
Acronym
Factor XIa Inhibitors for Secondary Prevention After Ischemic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Clinical Trials
Scientific Title
Factor XIa Inhibitors for Secondary Prevention After Ischemic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Clinical Trials
Scientific Title:Acronym
Factor XIa Inhibitors for Secondary Prevention After Ischemic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Clinical Trials
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Transient Ischemic Attack
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Factor XIa inhibition is an emerging antithrombotic strategy intended to reduce recurrent thrombotic events while preserving physiological hemostasis. Its role in secondary prevention after non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) remains uncertain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy outcome was recurrent ischemic stroke
Key secondary outcomes
The primary safety outcome was major bleeding.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies were deemed eligible for inclusion if they satisfied all of the following criteria: (1) they were double-blind, placebo-controlled randomized clinical trials; (2) they enrolled adults aged 18 years or older with recent non-cardioembolic ischemic stroke or high-risk TIA; and (3) they evaluated an oral or injectable FXIa inhibitor administered alongside background antiplatelet therapy.
Key exclusion criteria
. Studies were excluded if they enrolled patients exclusively for primary prevention, were limited to cardioembolic stroke or atrial fibrillation populations, or employed a nonrandomized design. Additionally, observational studies, case reports, case series, editorials, reviews, and conference abstracts without sufficient outcome data were excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kawashima |
Organization
Osaka Metropolitan University Hospital
Division name
Department of Neurosurgery
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
06-6645-2121
toshiyuki1986.331.24ser@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kawashima |
Organization
Osaka Metropolitan University Hospital
Division name
Department of Neurosurgery
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
06-6645-2121
Homepage URL
toshiyuki1986.331.24ser@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Hospital
Address
1-5-7 Asahimachi, Abeno-ku, Osaka City, Osaka
Tel
06-6645-2121
toshiyuki1986.331.24ser@gmail.com
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
| 2026 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
10.69854/jcq.2026.0022
Publication of results
Published
Result
URL related to results and publications
10.69854/jcq.2026.0022
Number of participants that the trial has enrolled
13889
Results
Compared with placebo, factor XIa inhibition was associated with a significant reduction in recurrent ischemic stroke (OR, 0.66; 95% CI, 0.58 to 0.76).
Results date posted
| 2026 | Year | 06 | Month | 28 | Day |
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
Completed
Date of protocol fixation
| 2026 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070177
