UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056077 |
|---|---|
| Receipt number | R000064078 |
| Scientific Title | The Effectiveness and Safety of Adjuvant Therapy with t-PA in Acute Ischemic Stroke |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 16:39:38 |
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Basic information
Public title
The Effectiveness and Safety of Adjuvant Therapy with t-PA in Acute Ischemic Stroke
Acronym
The Effectiveness and Safety of Adjuvant Therapy with t-PA in Acute Ischemic Stroke
Scientific Title
The Effectiveness and Safety of Adjuvant Therapy with t-PA in Acute Ischemic Stroke
Scientific Title:Acronym
The Effectiveness and Safety of Adjuvant Therapy with t-PA in Acute Ischemic Stroke
Region
| Japan | North America | South America |
| Australia | Europe | Africa |
Condition
Condition
Acute Ischemic Stroke
Classification by specialty
| Medicine in general | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current network meta-analysis (NMA) aims to systematically assess the effectiveness and safety of various antithrombotic agents as adjunctive therapies to t-PA in the treatment of Acute Ischemic Stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating no significant disability, at 90 days post-admission.
Key secondary outcomes
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
For the meta-analysis, we included studies that 1) involved adult patients diagnosed with acute ischemic stroke, 2) evaluated the efficacy of t-PA in combination with antithrombotic agents, and 3) reported relevant clinical outcomes, such as mortality, functional recovery, neurological assessment, and safety.
Key exclusion criteria
We excluded studies in which 1) thrombolysis was performed by thrombectomy or catheter, 2) a retrospective approach was employed, or 3) relevant clinical outcomes were not reported.
Target sample size
400
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
545-8585
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi, 545-8585, Japan
TEL
06-6645-3847
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
545-8585
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi, 545-8585, Japan
TEL
06-6645-3847
Homepage URL
toshiyuki1986.331.24ser@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University Hospita
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University Hospita
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 IRB
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi, 545-8585, Japan
Tel
06-6645-3847
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
| 2024 | Year | 11 | Month | 06 | 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
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064078
