Unique ID issued by UMIN | UMIN000002512 |
---|---|
Receipt number | R000003073 |
Scientific Title | Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset |
Date of disclosure of the study information | 2009/12/01 |
Last modified on | 2012/10/29 20:57:31 |
Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Combined therapy with intravenous recombinant tissue plasminogen activator (rt-PA) and edaravone in the acute ischemic stroke patients within 3 hours of onset
Japan |
Iscemic stroke
Neurology |
Others
NO
To investigate whether the safety and efficacy of the combined therapy with intravenous recombinant tissue plasminogen activator (IV rt-PA) and edaravone differs in the time of edaravone administration in the acute ischemic stroke patients within 3 hours of onset.
Safety,Efficacy
Clinical improvement
Hemorrhagic complication
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Group A:Start of edaravone administration within 15 minutes after starting IV rt-PA
A single alteplase(rt-PA) dose of 0.6 mg/kg is administered intravenously, with 10% given as a bolus, followed by continuous infusion of the remainder over 1 hour. Patients were also given 30mg edaravone over 30 minutes twice a day for 7 days.
Group B:Start of edaravone administration within 15 minutes after administration IV rt-PA
Administration procedure is same as above mentioned.
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients within 3 hours of onset time
2)Arterial lesion of anterior circulation on magnetic resonance angiography
1)Diffusion weighted imaging evidence of significant early ischemic change
2)Other exclusion criteria are same as Japan Alteplase Clinical Trial (J-ACT)
(stroke 2006;37:1810)
3)exclusion criteria of edaravone administraion mentioned in the package insert. Serume creatinine concentration over 1.5mg/dl
100
1st name | |
Middle name | |
Last name | Junya Aoki |
Kawasaki Medical School
Department of Stroke Medicine
577, Matsushima, Kurashiki
1st name | |
Middle name | |
Last name |
Kawasaki Medical School
Department of Stroke Medicine
Department of Stroke Medicine, Kawasaki Medical School
Department of stroke medicine, Kawasaki Medical School
Other
NO
2009 | Year | 12 | Month | 01 | Day |
Published
Completed
2009 | Year | 11 | Month | 01 | Day |
2009 | Year | 11 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2009 | Year | 09 | Month | 16 | Day |
2012 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003073
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |