UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takayuki Matsumoto
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
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	Takayuki Matsumoto, Shotaro Nakamura
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 03 Month 12 Day
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

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Publication of results	Unpublished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