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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034388
Receipt No. R000038184
Scientific Title Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic core
Date of disclosure of the study information 2019/03/31
Last modified on 2019/05/07

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Basic information
Public title Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic core
Acronym RESCUE-Japan LIMIT
Scientific Title Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic core
Scientific Title:Acronym RESCUE-Japan LIMIT
Region
Japan

Condition
Condition Acute large vessel occlusion
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes modified Rankin Scale 0-3 at 90 days
Key secondary outcomes 1) modified Rankin Scale 0-2 at 90 days
2) modified Rankin Scale 0-1 at 90 days
3) Distribution of patients across the ordinal modified Rankin scale
4) NIHSS improvement 8 points or more at 48 hours

Safety outcome
1) Symptomatic intracranial hemorrhage within 48 hours
2) Intracranial hemorrhage within 48 hours
3) Death
4) Recurrence of cerebral infarction within 90 days
5) Decompressive craniectomy within 7 days

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Best medical treatment for cerebral infarction
Interventions/Control_2 Best medical treatment for cerebral infarction with endovascular treatment
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Acute cerebral infarction patient
2) Patients's age => 18
3) Patients with NIHSS => 6
4) Prestroke Modified Rankin Score 0-1
5) ICA or M1 Occlusion on CT angiography or MR angiography
6) ASPECTS 3-5 or DWI-ASPECTS 3-5
7) Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.
8) Endovascular treatment can be initiatedwithin 60 minutes from randomization
9) Patient or Legally Authorized Representative has signed the Informed Consent form
Key exclusion criteria 1) Significant mass effect with midline shift
2) Known allergy to contrast agents
3) Evidence of acute intracranial hemorrhage
4) Pregnant
5) Clinical evidence of chronic occlusion
6) High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 second or PT-INR > 3.0)
7) Participating in any other therapeutic investigational trial
8) Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Yoshimura
Organization Hyogo College of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo
TEL 0798-45-6455
Email s-yoshi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Uchida
Organization Hyogo College of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo
TEL 0798-45-6458
Homepage URL http://www.rescue-japan.jp/
Email rescue-j@hyo-med.ac.jp

Sponsor
Institute Department of Neurosurgery, Hyogo College of 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
Address
Tel
Email

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
2019 Year 03 Month 31 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
2018 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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

Management information
Registered date
2018 Year 10 Month 05 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038184

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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