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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009227
Receipt No. R000010785
Scientific Title Post-marketing Registry On Treatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours
Date of disclosure of the study information 2012/11/01
Last modified on 2017/06/28

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Basic information
Public title Post-marketing Registry On Treatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours
Acronym PROTECT4.5
Scientific Title Post-marketing Registry On Treatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours
Scientific Title:Acronym PROTECT4.5
Region
Japan

Condition
Condition Cerebral infarction
Classification by specialty
Neurology Neurosurgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify patients' background who received edaravone with or without rt-PA within 4.5 hours after onset.To assess efficacy and safety of the combination therapy based on clinical outcome (mRS) by identifying severity (NIHSS, etc.).
To assess safety (including symptomatic intracranial hemorrhage: sICH) and efficacy according to timing of the combination of edaravone and rt-PA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)mRS score 3 months after onset (76-104 days) (Score 0 or 1 is defined as favorable clinical outcome)
2)sICH within 36 hours after the first dose of edaravone
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients receiving the first dose of edaravone within 4.5 hours after onset
2.Level of consciousness 0 to II-30 (Japan coma scale)
3.Motor weakness of upper/lower extremities
Key exclusion criteria 1.Patients whose serum creatinine was over 1.5 mg/dL at baseline
2.Patients with history of hypersensitivity to any component of edaravone
3.Patients judged as ineligible by the investigator because of poor general condition caused by severe liver disease (ex., cirrhosis) or cardiac disease (ex., cardiac failure) which requires treatment in hospital, or by infection which requires antibiotics treatment
4.Patients with mRS score ≥2 before onset
5.Patients with severe neuropathy (NIHSS score ≥23) before edaravone treatment
6.Patients with recurrent cerebral infarction(CI) who experienced previous CI within 3 months
7.Patients with CI associated with intracranial hemorrhage
8.Patients considered to be at higher risk for transient ischemic attack (TIA) by a doctor because his/her neurological signs improved rapidly
9.Patients judged as ineligible for other reasons by the investigator
Target sample size 10000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takenori Yamaguchi
Organization National Cardiovascular Center
Division name President Emeritus
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL 0
Email kouhara.akiko@mf.mt-pharma.co

Public contact
1st name of contact person
1st name
Middle name
Last name Ishizaki Kaoru
Organization Mitsubishi Tanabe Pharma Corporation
Division name Pharmacovigilance Department
Zip code
Address 2-6-6 Hirano-Machi, Chuo-ku, Osaka, Japan
TEL 06-6205-6212
Homepage URL
Email Ishizaki.Kaoru@mh.mt-pharma.co.jp

Sponsor
Institute Mitsubishi Tanabe Pharma Corporation
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.strokejournal.org/article/S1052-3057(16)30399-8/fulltext
Number of participants that the trial has enrolled
Results
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 12 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To identify patients' background who received edaravone with or without rt-PA within 4.5 hours after onset.
To assess efficacy and safety of the combination therapy based on clinical outcome (mRS) by identifying severity (NIHSS, etc.).
To assess safety (including symptomatic intracranial hemorrhage: sICH) and efficacy according to timing of the combination of edaravone and rt-PA.

Management information
Registered date
2012 Year 10 Month 31 Day
Last modified on
2017 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010785

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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