Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborator: Gastro-Intestinal Medical Care Research Center
• Treatments: Aspirin; Gefarnate; Rabeprazole

Criteria

Inclusion Criteria:

• patients with ischemic heart failure or vascular disease of brain

• patients taking low-dose aspirin to prevent relapse of vascular diseases

• patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy

• patients without active gastric and duodenal ulcers

• more than 20 years old

• outpatients

• patients written an informed consent

Exclusion Criteria:

• patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation

• patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack

• patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator

• patients who are treated with steroid hormones

• patients who are women of, pregnant and lactating and childbearing

• patients who are alcoholism

• patients who show the hypersensitivity for test drugs

• patients who are enrolled in another clinical study

• patients who are judged as unsuitable by investigator