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

UMIN ID: UMIN000002051

Registered date:05/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients who takes low-dose aspirin (less than 324 mg) daily for ischemic stroke that had developed 1 month or more before entry.
• Date of first enrollment: 2009/05/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 1) Symptoms 2) Quality of life 3) Erosion 4) Gastrroduodenal ulcer 5) Gastrointestinal bleeding

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
• Source(s) of Monetary Support: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University