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Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke

Preventive effect of proton-pump inhibitor for upper gastrointestinal injury induced by low-dose aspirin in patients with ischemic stroke - Japan Stroke Aspirin Trial (JSAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002051
Enrollment
500
Registered
2009-06-05
Start date
2009-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who takes low-dose aspirin (less than 324 mg) daily for ischemic stroke that had developed 1 month or more before entry.

Interventions

Subjects in PPI group are administered rabeprazole 10 mg once daily. Subjects in H2RA group are administered famotidine 20 mg twice daily.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1) Symptoms 2) Quality of life 3) Erosion 4) Gastrroduodenal ulcer 5) Gastrointestinal bleeding

Countries

Japan

Contacts

Public ContactTakayuki Matsumoto, Shotaro Nakamura

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

shonaka@iwate-med.ac.jp092-642-5261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026