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

This study has been completed.
Sponsor:
Collaborator:
Gastro-Intestinal Medical Care Research Center
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01051388
First received: January 15, 2010
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Cardio-cerebrovascular Disease
Drug: Low-dose PPI (Rabeprazole sodium)
Drug: High-dose PPI (Rabeprazole sodium)
Drug: Non-PPI (Gefarnate)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Endoscopic Recurrence of Gastric and/or Duodenal Ulcers [ Time Frame: 12 weeks after giving medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events [ Time Frame: 12 weeks after giving medication ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I
Low-dose PPI (Rabeprazole sodium 10 mg)
Drug: Low-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
Active Comparator: Group II
High-dose PPI (Rabeprazole sodium 20 mg)
Drug: High-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
Active Comparator: Group III
Non-PPI (Gefarnate)
Drug: Non-PPI (Gefarnate)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051388

Locations
Japan
Kobe University, School of Medicine
Kobe, Hyogo, Japan, 650-0017
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Gastro-Intestinal Medical Care Research Center
Investigators
Principal Investigator: Takeshi Azuma, M.D. , Ph.D. Kobe University, School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Takeshi Azuma, Kobe University, School of Medicine
ClinicalTrials.gov Identifier: NCT01051388     History of Changes
Other Study ID Numbers: TRIGID0801, UMIN000002901
Study First Received: January 15, 2010
Last Updated: April 1, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
The efficacy of PPI
Patients receiving low-dose aspirin for vascular protection

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Rabeprazole
Gefarnate
Proton Pump Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014