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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001808
Receipt No. R000002183
Scientific Title Fluid attenuated inversion recovery imaging based intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Date of disclosure of the study information 2009/07/01
Last modified on 2014/06/23

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Basic information
Public title Fluid attenuated inversion recovery imaging based intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Acronym Fluid attenuated inversion recovery imaging based intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Scientific Title Fluid attenuated inversion recovery imaging based intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Scientific Title:Acronym Fluid attenuated inversion recovery imaging based intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Region
Japan

Condition
Condition Ischemic stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of intravenous recombinant tissue plasminogen activator (rt-PA) therapy in the acute ischemic stroke patients whose onset time is suspected to be within 3 hours based on the magnetic resonance imaging study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Clinical improvement
2)hemorrhagic complication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravenous recombinant tissue plasminogen activator (rt-PA) therapy
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with unknown onset time
2) Arterial lesion of anterior circulation on magnetic resonance angiography
3) The findings of fluid attenuated inversion recovery imaging is negative
Key exclusion criteria 1) Patients with suspected onset time is over 24 hours
2) Diffusion weighted imaging evidence of significant early ischemic change
3) Other criteria are same as Japan Alteplase Clinical Trial (J-ACT) (stroke 2006;37:1810)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Aoki
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address 577, Matsushima, Kurashiki
TEL 086-462-1111
Email aojyun@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Aoki
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address 577, Matsushima, Kurashiki
TEL 086-462-1111
Homepage URL
Email aojyun@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of stroke medicine, Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
RESULTS:Subject comprised 24 patients (median age, 83 [68-90] years; 8 [33%] males). Thirteen (54%) patients had the wake-up stroke, remain 11 (46%) patients had the unwitness stroke. Eight (33%) patients had the ICAO (ICAO group), and 16 (67%) had the MCAO (MCAO group). NIHSS score was slightly higher in the ICAO group than the MCAO group (18 [17-20] vs. 16 [10-20], p=0.085). Median interval between the last seen normal time and admission was similar between patients in the ICAO group and the MCAO group (5.9 h [5.0-12.4] vs. 5.6 h [4.2-12.9], p=0.602). DWI-ASPECTS on admission tended to be higher in the ICAO and the MCAO groups (9 [8-10] vs. 8 [6-9], p=0.086). During the 7 days after stroke, none of the patients with ICAO and the MCAO groups experienced symptomatic cerebral hemorrhage (p=1.000). Regarding efficacy outcome, only 1 (13%) of the 8 patients in the ICAO group and 7 (44%) of the 16 patients in the MCAO group had early recanalization. Thus, the rate of dramatic recovery at day 7 was significantly lower in the ICAO group than the MCAO group (13% vs. 63%, p=0.033). Among 17 patients with pre-morbid mRS 0-2, none (0%) of the 4 patients with ICAO group and 8 (62%) of the 13 patients achieved favorable outcome (p=0.082).
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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 Month 23 Day
Date of closure to data entry
2014 Year 06 Month 23 Day
Date trial data considered complete
2014 Year 06 Month 23 Day
Date analysis concluded
2014 Year 06 Month 23 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 28 Day
Last modified on
2014 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002183

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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