UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001808 |
|---|---|
| Receipt number | 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 16:00:51 |
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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
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
aojyun@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Stroke Medicine, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002183
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