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Completed

NCT Number: NCT01051388

Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

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.

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Key information

Conditions

Cardio-cerebrovascular Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kobe University, School of Medicine

Kobe, Hyōgo, 650-0017, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose PPI (Rabeprazole sodium)

Drug

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

High-dose PPI (Rabeprazole sodium)

Drug

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

Non-PPI (Gefarnate)

Drug

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

Primary outcomes

  1. Endoscopic Recurrence of Gastric and/or Duodenal Ulcers

    Time frame: 12 weeks after giving medication

Secondary outcomes

  1. Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events

    Time frame: 12 weeks after giving medication

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Gastro-Intestinal Medical Care Research Center

Registry information

Official study title

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

Acronym: CARE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2010
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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