Upper gastrointestinal mucosal injury
Conditions
Interventions
Dabigatran 300mg/day + Rabeprazole 10mg/day for 4 weeks
Dabigatran 300mg/day + Famotidine 20mg/day for 4 weeks
Dabigatran 300mg/day + Rebamipide 300mg/day for 4 weeks
Sponsors
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patients 20 years or older, without distinction of sex b. Patients who receive dabigatran for non-valvular atrial fibrillation c. Written informed consent is required from all participants
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of upper endoscopic findings(redness, petechia, erosion, and ulcer) after administration of dabigatran for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Evaluation of abdominal symptoms b. The effect of various antiulcer agents in patients with dabigatran-induced gastrointestinal mucosal injuries | — |
Countries
Japan
Contacts
Public ContactHirotoshi Hamaguchi
Kobe University Hospital Department of neurology
Outcome results
None listed