UMIN-CTR Clinical Trial

Basic information
Public title	Plasma xantine oxidoreductase (XOR) activity in patients with acute cerebral infarction
Acronym	Acute cerebral infarction and plasma XOR activity
Scientific Title	Plasma xantine oxidoreductase (XOR) activity in patients with acute cerebral infarction
Scientific Title:Acronym	Acute cerebral infarction and plasma XOR activity
Region	Japan

Condition
Condition	Acute cerebral infarction
Classification by specialty	Cardiology Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical significance of plasma xanthine oxidoreductase levels in acute cerebral infarction
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationships between plasma xanthine oxidoreductase activity and stroke severity in patients with acute cerebral infarction.
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 with acute cerebral infarction admitted to our hospital within 2 days after onset 2) Patients who are diagnosed with ischemic stroke by the present history, neurological examination, and CT or MRI 3) Patients or his/her legally authorized representative who give written informed consent.
Key exclusion criteria	Patients who are not diagnosed with acute cerebral infarction
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jogi Hagii
Organization	Hirosaki Stroke and Rehabilitation Center
Division name	Internal Medicine
Zip code
Address	1-2-1 Ougi-machi Hirosaki, Aomori
TEL	0172-28-8220
Email	j_hagii@reimeikyou.jp

Public contact
Name of contact person	1st name Middle name Last name Jogi Hagii
Organization	Hirosaki Stroke and Rehabilitation Center
Division name	Internal Medicine
Zip code
Address	1-2-1 Ougi-machi Hirosaki, Aomori
TEL	0172-28-8220
Homepage URL
Email	j_hagii@reimeikyou.jp

Sponsor
Institute	Hirosaki Stroke and Rehabilitation Center
Institute
Department

Funding Source
Organization	Sanwa Kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sanwa Kagaku Kenkyusho Co., Ltd.
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	弘前脳卒中・リハビリテーションセンター（青森県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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	2015 Year 11 Month 16 Day
Date of IRB	2015 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 07 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: Observation Objective recruitment: Patients admitted to the hospital within 2 days after onset with a diagnosis of acute cerebral infarction between March 2016 to March 2017 Primary outcome: Relationships between plasma xanthine oxidoreductase activity and stroke severity in patients with acute cerebral infarction Scondary outcome: 1) Effect of patient charactaristics and other biomarkers on plasma XOR activity 2) Change in time-dependent plasma XOR activity in patients with acute cerebral infarction

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024419