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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030332
Receipt No. R000034452
Scientific Title NHO Microbleeds in relationship to antithrombotic agents study
Date of disclosure of the study information 2017/12/10
Last modified on 2018/09/25

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Basic information
Public title NHO Microbleeds in relationship to antithrombotic agents study
Acronym NOBLESSE study
Scientific Title NHO Microbleeds in relationship to antithrombotic agents study
Scientific Title:Acronym NOBLESSE study
Region
Japan

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

Objectives
Narrative objectives1 To determine whether progression of cerebral microbleeds is related to the types of antithrombotic agents in patients with ischemic stroke.
Basic objectives2 Others
Basic objectives -Others The relationship between progression of cerebral microbleeds and the types of antithrombotic agents.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numbers of cerebral microbleeds signal on T2*-weighted gradient-echo
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Ischemic stroke patients who take antithrombotic agent within three months of the ischemic stroke onset
(2) 20 years and over at the time of entry
(3) Male and Female
(4) Patients who are able to receive MRI
(5) Patients who are able to visit the hospital one year later
(6) Provision of written informed consent
Key exclusion criteria (1) Patients who have a plan to stop antithrombotic agent
(2) Patients who have a plan to implant medical device not permitted at MRI examination.
(3) Patients who cannot take MRI one year later
(4) Patients that the doctor in charge judge not to be appropriate for participation in this study
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asako Nakamura
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Cerebrovascular Medicine and Neurology
Zip code
Address 1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Email asakoro1012@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asako Nakamura
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Cerebrovascular Medicine and Neurology
Zip code
Address 1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Homepage URL
Email asakoro1012@yahoo.co.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
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
2017 Year 12 Month 10 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 Observational study

Management information
Registered date
2017 Year 12 Month 10 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034452

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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