Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation (CARE)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Cardio-cerebrovascular Disease

Treatments: Drug: High-dose PPI (Rabeprazole sodium); Drug: Non-PPI (Gefarnate); Drug: Low-dose PPI (Rabeprazole sodium)

Study type: Interventional

Funder types: Other

Identifiers

NCT01051388

TRIGID0801

UMIN000002901 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 280 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 3 patient groups

Group I

Active Comparator group

Description:

Low-dose PPI (Rabeprazole sodium 10 mg)

Treatment:

Drug: Low-dose PPI (Rabeprazole sodium)

Group II

Active Comparator group

Description:

High-dose PPI (Rabeprazole sodium 20 mg)

Treatment:

Drug: High-dose PPI (Rabeprazole sodium)

Group III

Active Comparator group

Description:

Non-PPI (Gefarnate)

Treatment:

Drug: Non-PPI (Gefarnate)