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

Primary Purpose

Cardio-cerebrovascular Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Low-dose PPI (Rabeprazole sodium)
High-dose PPI (Rabeprazole sodium)
Non-PPI (Gefarnate)
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardio-cerebrovascular Disease focused on measuring The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kobe University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

Low-dose PPI (Rabeprazole sodium 10 mg)

High-dose PPI (Rabeprazole sodium 20 mg)

Non-PPI (Gefarnate)

Outcomes

Primary Outcome Measures

Endoscopic Recurrence of Gastric and/or Duodenal Ulcers

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2010
Last Updated
April 1, 2011
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Gastro-Intestinal Medical Care Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01051388
Brief Title
Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation
Acronym
CARE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Gastro-Intestinal Medical Care Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio-cerebrovascular Disease
Keywords
The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Low-dose PPI (Rabeprazole sodium 10 mg)
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
High-dose PPI (Rabeprazole sodium 20 mg)
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Non-PPI (Gefarnate)
Intervention Type
Drug
Intervention Name(s)
Low-dose PPI (Rabeprazole sodium)
Intervention Description
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
Intervention Type
Drug
Intervention Name(s)
High-dose PPI (Rabeprazole sodium)
Intervention Description
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
Intervention Type
Drug
Intervention Name(s)
Non-PPI (Gefarnate)
Intervention Description
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
Primary Outcome Measure Information:
Title
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Time Frame
12 weeks after giving medication
Secondary Outcome Measure Information:
Title
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
Time Frame
12 weeks after giving medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Azuma, M.D., Ph.D.
Organizational Affiliation
Kobe University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe University, School of Medicine
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000003537&language=J
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Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

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