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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002051
Receipt No. R000002286
Scientific Title Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke
Date of disclosure of the study information 2009/06/05
Last modified on 2016/06/05

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Basic information
Public title Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke
Acronym Japan Stroke Aspirin Trial (JSAT)
Scientific Title Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke
Scientific Title:Acronym Japan Stroke Aspirin Trial (JSAT)
Region
Japan

Condition
Condition Patients who takes low-dose aspirin (less than 324 mg) daily for ischemic stroke that had developed 1 month or more before entry.
Classification by specialty
Medicine in general Gastroenterology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the preventive effect of proton pump inhibitor (PPI) and histamine 2 receptor antagonist (H2RA) for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Symptoms
2) Quality of life
3) Erosion
4) Gastrroduodenal ulcer
5) Gastrointestinal bleeding
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Subjects in PPI group are administered rabeprazole 10 mg once daily.
Interventions/Control_2 Subjects in H2RA group are administered famotidine 20 mg twice daily.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ischemic stroke that had developed 1 month or more before, 1) who are taking low-dose aspirin (less than 324 mg) daily, 2) who has some upper gastrointestinal symptoms (Score 1 or more for Frequency Scale for the Symptoms of GERD), and 3) in whom neither ulcers nor bleeding are observed at the initial endoscopy.
Key exclusion criteria 1) Subjects in whom ulcers (3 mm or more in diameter) at the initial endoscopy.
2) Subjects who has been taking PPI at entry.
3) Subjects who has taken some NSAIDs other than aspirin within 1 month.
4) Subjects with a history of allergy for aspirin, rabeprazole or famotitine.
5) Subjects with severe liver damage, renal dysfunction, or congestive heart failure.
6) Subjects with malignancy.
7) Others.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Matsumoto
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Clinical Science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5261
Email tmatsumo@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Matsumoto, Shotaro Nakamura
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Clinical Science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5261
Homepage URL
Email shonaka@iwate-med.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization Other
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
2009 Year 06 Month 05 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
2009 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 05 Day
Last modified on
2016 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002286

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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