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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||
Condition | Antiphospholipid syndrome | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |