Clinical trial NCT01051388: Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardio-cerebrovascular Disease
Keywords: The efficacy of PPI
Patients receiving low-dose aspirin for vascular protection
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Gastro-Intestinal Medical Care Research Center
First posted: 2010-01-18
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
timeFrame: 12 weeks after giving medication
Secondary outcomes:
measure: Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
timeFrame: 12 weeks after giving medication
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University, School of Medicine
state: Hyogo
Study officials:
affiliation: Kobe University, School of Medicine
name: Takeshi Azuma, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: