Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051388

Acronym

CARE

Enrollment

280

Registered

2010-01-18

Start date

2008-08-31

Completion date

2010-12-31

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio-cerebrovascular Disease

Keywords

The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection

Brief 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.

Detailed 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).

Interventions

DRUGLow-dose PPI (Rabeprazole sodium)

PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three

DRUGHigh-dose PPI (Rabeprazole sodium)

PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)

DRUGNon-PPI (Gefarnate)

The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers	12 weeks after giving medication

Secondary

Measure	Time frame
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events	12 weeks after giving medication

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026