Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).

Official Title
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Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study

Conditions
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Cardio-cerebrovascular Disease

Intervention / Treatment
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* Drug: Low-dose PPI (Rabeprazole sodium)
* Drug: High-dose PPI (Rabeprazole sodium)
* Drug: Non-PPI (Gefarnate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Low-dose PPI (Rabeprazole sodium 10 mg) | Drug: Low-dose PPI (Rabeprazole sodium)<br>* PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three<br>|
| Active Comparator: Group II<br>High-dose PPI (Rabeprazole sodium 20 mg) | Drug: High-dose PPI (Rabeprazole sodium)<br>* PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)<br>|
| Active Comparator: Group III<br>Non-PPI (Gefarnate) | Drug: Non-PPI (Gefarnate)<br>* The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Recurrence of Gastric and/or Duodenal Ulcers |  | 12 weeks after giving medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events |  | 12 weeks after giving medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection