UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002051 |
|---|---|
| Receipt number | 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 12:46:24 |
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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
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
shonaka@iwate-med.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002286
