Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatra
Phase 4
- Conditions
- pper gastrointestinal mucosal injury
- Registration Number
- JPRN-UMIN000006344
- Lead Sponsor
- Kobe University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
a. Patients with severe renal failure including those on hemodialysis (creatinine clearance of less than 30mL/min) b. Patients having organic lesions with a risk of bleeding (within 6 months after the onset of hemorrhagic stroke) c. Patients with a spinal/epidural catheter inserted or those in which the spinal/epidural catheter was just removed within 1 hour d. Patients with a history of hypersensitivity for tabeprazole, famotidine, or rebamipide e. Patients who are taking itraconazole f. Patients judged by investigators as ineligible for study enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of upper endoscopic findings(redness, petechia, erosion, and ulcer) after administration of dabigatran for 4 weeks
- Secondary Outcome Measures
Name Time Method a. Evaluation of abdominal symptoms b. The effect of various antiulcer agents in patients with dabigatran-induced gastrointestinal mucosal injuries