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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021488
Receipt No. R000024783
Scientific Title Randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion - A prospective, multicenter, randomized trial
Date of disclosure of the study information 2016/04/01
Last modified on 2021/09/21

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Basic information
Public title Randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion - A prospective, multicenter, randomized trial
Acronym Efficiency of alone endovascular therapy for acute ischemic stroke patients
Scientific Title Randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion - A prospective, multicenter, randomized trial
Scientific Title:Acronym Efficiency of alone endovascular therapy for acute ischemic stroke patients
Region
Japan

Condition
Condition Acute ischemic stroke
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We perform this study to make clear about efficicacy of endovascular alone therapy for ischemic stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of Modified Rankin Scale 0-2 at 90 days after onset. (Noninferior)
Key secondary outcomes Rate of asymptomatic and symptomatic intracranial hemorrhage at 24 hours after onset.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Endovascular therapy
Interventions/Control_2 Endovascular therapy
intravenous tissue plasminogen
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients of from 18 to 85 years old
2.Continued clinical symptoms in patoents with acute cerebral infarction
3.Pre mRS within 2
4.Patients with ICA or M1 occlusion and be able to puncture within 4 hours.
5.DWI-ASPECTS more than 5 or ASPECTS more than 6 at pre endovascular therapy
6.NIHSS more than 6
7.Research consent have been obtained in writing from the person or alternative person
Key exclusion criteria 1.Patients with a hypersensitivity to contrast
2.Past history of puncture artery hemostasis
3.Patients with severe urine function
4.A lactating or pregnant patients
5.Patient expected life expectancy within 90 days
6.Ineligible for tPA therapy patients
7.Patient deemed unfit to conduct this testing responsible physician or trial division
Target sample size 200

Research contact person
Name of lead principal investigator
1st name KAZUMI
Middle name
Last name KIMURA
Organization Nippon Medical School
Division name Neurology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL 03-3822-2131
Email k-kimura@nms.ac.jp

Public contact
Name of contact person
1st name KENTARO
Middle name
Last name SUZUKI
Organization Nippon Medical School
Division name Neurological Science
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL 03-3822-2131
Homepage URL
Email kentarow@nms.ac.jp

Sponsor
Institute Nippon Medical School
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 Nippon Medical School
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
Tel 03-3822-2131
Email clinicaltrial@nms.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
2016 Year 04 Month 01 Day

Related information
URL releasing protocol https://journals.sagepub.com/doi/10.1177/1747493019840932?url_ver=Z39.88-2003&rfr_id=ori:rid:crossre
Publication of results Published

Result
URL related to results and publications https://jamanetwork.com/journals/jama/fullarticle/2775278
Number of participants that the trial has enrolled 204
Results Among 204 patients (median age, 74 years; 62.7% men; median National Institutes
of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with nosignificant between-group difference ( P = .18 for noninferiority).
Results date posted
2021 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 01 Month 19 Day
Baseline Characteristics acute ischemic stroke due to large
vessel occlusion
Participant flow We checked modified Rankin Scale at 90 days from onset.
Adverse events Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; P = .78).
Outcome measures mRS at 90 days
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
2016 Year 10 Month 27 Day
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 16 Day
Last modified on
2021 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024783

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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