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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011623
Receipt No. R000013597
Scientific Title Efficacy of steroid therapy for prevention of recurrent cerebral amyloid angiopathy-related hemorrhage.
Date of disclosure of the study information 2013/09/02
Last modified on 2015/05/19

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Basic information
Public title Efficacy of steroid therapy for prevention of recurrent cerebral amyloid angiopathy-related hemorrhage.
Acronym Efficacy of steroid therapy for prevention of recurrent cerebral amyloid angiopathy-related hemorrhage.
Scientific Title Efficacy of steroid therapy for prevention of recurrent cerebral amyloid angiopathy-related hemorrhage.
Scientific Title:Acronym Efficacy of steroid therapy for prevention of recurrent cerebral amyloid angiopathy-related hemorrhage.
Region
Japan

Condition
Condition Cerebral amyloid angiopathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cerebral amyloid angiopathy-related hemorrhage typically presents recurrent or multiple lobar hemorrhage. Hypertension and antithrombotic therapy are known as risk factors for hemorrhage in this disorder, but valid prophylactics are still unknown. The efficacy of oral corticosteroid therapy for prevention of re-bleeding has been reported in recent years. We will investigate the efficacy of oral 2.5mg and 10mg prednisolone therapy for preventing hemorrhage in this disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The subjects who had been diagnosed as CAA and agreed with administration of corticosteroid were randomly divided into two groups, 2.5mg and 10mg prednisolone. We will evaluate the time from baseline study to re-bleeding resulting from CAA within 18 months observational period.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Non-steroid group
Observational period <= 18 months
Interventions/Control_2 2.5mg prednisolone group
Observational period <= 18 months, daily administration
Interventions/Control_3 10mg prednisolone group
Observational period <= 18 months, daily administration
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
41 years-old <=
Age-upper limit
86 years-old >=
Gender Male and Female
Key inclusion criteria The subjects are patients who suffer from cerebral hemorrhage and are diagnosed as CAA according to Boston criteria. They should be classified into three groups, probable CAA with supporting pathology, probable CAA or possible CAA with amyloid deposition disclosed by PiB-PET imaging.
Informed consent about the objects, methods, expected results and hazard of this study must be obtained from the patients with CAA-related hemorrhage.
Key exclusion criteria Patients who have met these exclusion criteria should be excluded.
Age is younger than 41 years old or older than 86 years old when informed consent was obtained.
Patients who have uncontrolled hypertension (systolic blood pressure>=160mmHg or diastolic blood pressure>=100mmHg), taken antithrombotic medication (antiplatelet or anticoagulant drug), abnormal glucose tolerance (HbA1c>=6.5%(NGSP)).
Patients who may have difficulty in adherence to continuous and regular medication.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Hashimoto
Organization Aizawa Hospital
Division name Department of Neurology
Zip code
Address 2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL 0263-33-8600
Email sinke-dr@ai-hosp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Doden
Organization Aizawa Hospital
Division name Department of Neurology
Zip code
Address 2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL 0263-33-8600
Homepage URL
Email aidr214@ai-hosp.or.jp

Sponsor
Institute Aizawa Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 相澤病院(長野県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 02 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 Terminated
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 02 Day
Last modified on
2015 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013597


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