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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000342
Receipt No. R000000395
Scientific Title Japan Antiphospholipid syndrome-Stroke Prevention Study
Date of disclosure of the study information 2006/03/01
Last modified on 2018/09/13

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Basic information
Public title Japan Antiphospholipid syndrome-Stroke Prevention Study
Acronym JASPRES
Scientific Title Japan Antiphospholipid syndrome-Stroke Prevention Study
Scientific Title:Acronym JASPRES
Region
Japan

Condition
Condition Antiphospholipid syndrome
Classification by specialty
Medicine in general Hematology and clinical oncology Neurology
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the guideline of the management in antiphospholipid syndrome patients with stroke and arterial thrombosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Cerebral Infarct Score in MRI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Warfarin, INR 2.0, 2 years
Interventions/Control_2 cilostazol, 200mg/day, 2 years or ticlopidine, 100-200mg/day, 2 years
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 Patients with antiphospholipid syndrome who fulfil the Sapporo Criteria and have cerebral infarct
Key exclusion criteria Female patients who are pregnant or plans to be pregnant
Patients who cannot have warfarin or antiplatetet drugs
Patients who are required to take warfarin
Patients with severe hepatic, renal or cardiac failure
Other inadequate patients for this clinical trial
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Atsumi
Organization Hokkaido University Hospital
Division name Medicine II
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-706-5915
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Atsumi
Organization Hokkaido University Hospital
Division name Medicine II
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-706-5915
Homepage URL
Email at3tat@med.hokudai.ac.jp

Sponsor
Institute JASPRES team
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2006 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
discontineued
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
2006 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 31 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 10 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 02 Month 28 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000395

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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