UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000342 |
|---|---|
| Receipt number | 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 10:09:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
at3tat@med.hokudai.ac.jp
Sponsor or person
Institute
JASPRES team
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000395
