Unique ID issued by UMIN | UMIN000021488 |
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Receipt number | 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 13:25:15 |
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
Efficiency of alone endovascular therapy for acute ischemic stroke patients
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
Efficiency of alone endovascular therapy for acute ischemic stroke patients
Japan |
Acute ischemic stroke
Neurology | Radiology | Neurosurgery |
Others
NO
We perform this study to make clear about efficicacy of endovascular alone therapy for ischemic stroke.
Efficacy
Confirmatory
Pragmatic
Not applicable
Rate of Modified Rankin Scale 0-2 at 90 days after onset. (Noninferior)
Rate of asymptomatic and symptomatic intracranial hemorrhage at 24 hours after onset.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine | Device,equipment |
Endovascular therapy
Endovascular therapy
intravenous tissue plasminogen
18 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
200
1st name | KAZUMI |
Middle name | |
Last name | KIMURA |
Nippon Medical School
Neurology
113-8603
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-2131
k-kimura@nms.ac.jp
1st name | KENTARO |
Middle name | |
Last name | SUZUKI |
Nippon Medical School
Neurological Science
113-8603
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-2131
kentarow@nms.ac.jp
Nippon Medical School
None
Other
Nippon Medical School
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-2131
clinicaltrial@nms.ac.jp
NO
2016 | Year | 04 | Month | 01 | Day |
https://journals.sagepub.com/doi/10.1177/1747493019840932?url_ver=Z39.88-2003&rfr_id=ori:rid:crossre
Published
https://jamanetwork.com/journals/jama/fullarticle/2775278
204
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).
2021 | Year | 09 | Month | 21 | Day |
2021 | Year | 01 | Month | 19 | Day |
acute ischemic stroke due to large
vessel occlusion
We checked modified Rankin Scale at 90 days from onset.
Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; P = .78).
mRS at 90 days
Completed
2016 | Year | 03 | Month | 15 | Day |
2016 | Year | 10 | Month | 27 | Day |
2017 | Year | 01 | Month | 01 | Day |
2019 | Year | 10 | Month | 31 | Day |
2019 | Year | 11 | Month | 30 | Day |
2016 | Year | 03 | Month | 16 | Day |
2021 | Year | 09 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024783
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