UMIN-CTR Clinical Trial

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

Cerebral infarction

Classification by specialty

Neurology	Neurosurgery	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Mitsubishi Tanabe Pharma Corporation

Institute

Department

Personal name

Organization

Mitsubishi Tanabe Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2012

Year

10

Month

31

Day

Last modified on

2017

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010785