Unique ID issued by UMIN | C000000139 |
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Receipt number | R000000206 |
Scientific Title | MCA Embolism Local Fibrinolytic Intervention Trial |
Date of disclosure of the study information | 2005/09/08 |
Last modified on | 2007/04/15 14:04:47 |
MCA Embolism Local Fibrinolytic Intervention Trial
MELT Japan
MCA Embolism Local Fibrinolytic Intervention Trial
MELT Japan
Japan |
Middle cerebral artery embolism
Neurology | Radiology | Neurosurgery |
Others
NO
To determine the clinical efficacy and safety of intra-arterial Urokinase in patients with acute MCA stroke of less than 6 hours duration.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Proportion of patients with slight or no neurologic disability at 90 days, as defined by a modified Rankin score of 2 or less. The ratio is compared between UK and conservative group.
Proportion of patients with slight or no neurologic disability at 90 days, as defined by a modified Rankin score of 1 or less. The ratio of good outcome is compared between UK and conservative group.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine | Maneuver |
To receive local intraarterial Urokinase (infusion of 12,000U per 5min will be repeated until a total dose reaches 60,000U, two hours pass after starting infusion, or complete recanalization is achieved.)
No intraarterial intervention. Intravenous infusion of thrombolytic agents is prohibited in the both groups.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Patients with acute ischemic stroke of less than 6 hours duration caused by angiographically proven occlusion of the middle cerebral artery (MCA, M1 or M2), National Institutes of Health Stroke Scale (NIHSS) score of at least.
NIHSS>22, rapid improvement, history of stroke within previous 90 days, seizures at onset, clinical presentation suggestive of subarachnoid hemorrhage, previous history or intracranial hemorrhage at any time, neoplasm, or subarachnoid hemorrhage, septic embolism, suspected lacunar stroke, surgery, biopsy of a parenchymal organ, trauma with internal injuries or lumbar puncture within 30 days, head trauma within 90 days, active or recent hemorrhage within 30 days, known hemorrhagic diathesis, known contrast sensitivity, sustained BP > 180/100, INR > 1.7, hemorrhage or major early infarction signs on CT scan.
200
1st name | |
Middle name | |
Last name | Akira Ogawa |
Iwate Medical University
Neurosurgery
19-1 Uchimaru Morioka Iwate Japan
019-651-5111
1st name | |
Middle name | |
Last name | Takashi Inoue |
Iwate Medical University
Neurosurgery
19-1 Uchimaru Morioka Iwate Japan
019-651-5111
http://melt.umin.ac.jp
melt-adm@umin.ac.jp
MELT Study Group
Ministry of Health, Labour and Welfare
Japan
NO
2005 | Year | 09 | Month | 08 | Day |
https://endai.umin.ac.jp/islet/melt/protocol/intro.htm
Published
https://endai.umin.ac.jp/islet/melt/
A total of 114 patients underwent randomization, 57 patients in each group. Background characteristics were comparable between the two groups. The primary endpoint of favorable outcome (mRS 0-2) at 90 days was somewhat more frequent in the UK group than in the control group (49.1% and 38.6%, odds ratio 1.54, 95% confidence interval 0.73 to 3.23) but did not reach significant level (p = 0.345). However, excellent functional outcome (mRS 0-1) at 90 days, a preplanned secondary endpoint, was more frequent in the UK group than in the control group (42.1% and 22.8%, p=0.045, odds ratio 2.46, 95% confidence interval 1.09 to 5.54). There were significantly more patients with NIHSS 0 or 1 at 90 days in the UK group than the control group (p=0.017). The 90-day cumulative mortality was 5.3% in the UK group and 3.5% in the control group (p=1.000), and intracerebral hemorrhage within 24 hours of treatment occurred in 9% and 2%, respectively (p=0.206).
Completed
2001 | Year | 12 | Month | 14 | Day |
2002 | Year | 01 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
2007 | Year | 04 | Month | 01 | Day |
The trial was aborted prematurely and the primary end point did not reach statistical significance. Nevertheless, the secondary analyses suggested that intra-arterial fibrinolysis has the potential to increase the likelihood of excellent functional outcome.
2005 | Year | 09 | Month | 08 | Day |
2007 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000206
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