Serial endoscopic evaluation of aspirin-induced gastroduodenal injury: pevention of peptic ulcer with proton pump inhibitor in patients taking low-dose aspirin

UMIN ID: UMIN000003264

Registered date:28/02/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Coronay artery disase Gastroduodenal ulcer
• Date of first enrollment: 2008/06/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Raveprazole (10 mg) will be given for 3 months in patinets who undergo PCI and take aspirin, after confirming the absence of endoscopic upper GI ulcer.
Placebo will be given for 3 months in patinets who undergo PCI and take aspirin, after confirming the absence of endoscopic upper GI ulcer.

Outcome(s)

• Primary Outcome: Gastroduodenal Ulcer or bleeding, Upper Gastrointestinal symptom and decrease in hemoglobin level 3 month after percutaneous coronary intervention
• Secondary Outcome: Severity of gastroduodenal mucosal injury evaluated with LANZA score

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients having an episode of adverse effect by rabeprazole or other proton pump inhibitor Patients with severe liver or renal dysfunction Patients with NYHA III or IV heart failure Patients with pregnancy (including possible), or nursing patients Patients who are not judged to be appropreate by a study conductor

Related Information

• Primary Sponsor: Nippon Medical School
• Source(s) of Monetary Support: Nippon Medical School