UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Antiphospholipid syndrome-Stroke Prevention Study
Title of the study (Brief title)	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	Tatsuya Atsumi
Organization	Hokkaido University Hospital
Division name	Medicine II
Address	N14 W5, Kita-ku, Sapporo
TEL	011-706-5915
Email

Public contact
Name of contact person	Tatsuya Atsumi
Organization	Hokkaido University Hospital
Division name	Medicine II
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2006 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	discontineued
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