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

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 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


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

Value
https://center6.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