UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000139
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

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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 or person

Institute

MELT Study Group

Institute

Department

Personal name



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

Value
https://center6.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