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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000139
Receipt No. 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

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Basic information
Public title MCA Embolism Local Fibrinolytic Intervention Trial
Acronym MELT Japan
Scientific Title MCA Embolism Local Fibrinolytic Intervention Trial
Scientific Title:Acronym MELT Japan
Region
Japan

Condition
Condition Middle cerebral artery embolism
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the clinical efficacy and safety of intra-arterial Urokinase in patients with acute MCA stroke of less than 6 hours duration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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
Medicine Maneuver
Interventions/Control_1 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.)
Interventions/Control_2 No intraarterial intervention. Intravenous infusion of thrombolytic agents is prohibited in the both groups.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Ogawa
Organization Iwate Medical University
Division name Neurosurgery
Zip code
Address 19-1 Uchimaru Morioka Iwate Japan
TEL 019-651-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Inoue
Organization Iwate Medical University
Division name Neurosurgery
Zip code
Address 19-1 Uchimaru Morioka Iwate Japan
TEL 019-651-5111
Homepage URL http://melt.umin.ac.jp
Email melt-adm@umin.ac.jp

Sponsor
Institute MELT Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 09 Month 08 Day

Related information
URL releasing protocol https://endai.umin.ac.jp/islet/melt/protocol/intro.htm
Publication of results Published

Result
URL related to results and publications https://endai.umin.ac.jp/islet/melt/
Number of participants that the trial has enrolled
Results
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).
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 Completed
Date of protocol fixation
2001 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2002 Year 01 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 04 Month 01 Day

Other
Other related information 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.

Management information
Registered date
2005 Year 09 Month 08 Day
Last modified on
2007 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000206

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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