Non-valvular atrial fibrillation
Conditions
Interventions
Administration of a proton pump inhibitor
Administration of an H2 receptor antagonists
Administration of a gastric mucosal protective drug
Sponsors
Committee on Proper Use of Anticoagulant Therapies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for Part 1 Patients who meet all of the following criteria will be included in Part 1 of the study: 1. Have non-valvular atrial fibrillation (paroxysmal, persistent, or permanent) (inpatients or outpatients) 2. Planned to be started on dabigatran therapy for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation 3. Do not have any dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, or epigastric discomfort) 4. Aged 20 years or older at the time of consent 5. Capable of providing written consent in person to participate in the study Inclusion criteria for Part 2 Participants of Part 1 who meet all of the following criteria will proceed to Part 2 of the study: 1. Receiving dabigatran for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation 2. Have experienced dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, and/or epigastric discomfort) with GOS (Global Overall Severity) scale score of 3 or higher during Part 1 of the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Have a history of hypersensitivity to any ingredients of the dabigatran preparation 2. Undergoing dialysis or have severe renal disorder (creatinine clearance < 30 mL/min*1) 3. Have hemorrhagic symptoms, hemorrhagic diathesis, or hemostatic disturbance 4. Have any organic lesion posing a clinically significant risk for bleeding (including onset of hemorrhagic stroke within the past 6 months) 5. Have a spinal/epidural catheter in place 6. Receiving (oral) itraconazole 7. Have undergone surgery for upper gastrointestinal tract (e.g., esophageal, gastric) resection or vagotomy 8. Have any organic disease confirmed by upper gastrointestinal endoscopy or X-ray performed within one year prior to the consent 9. Women with established or possible pregnancy, nursing mothers, or women who desire to become pregnant during the study participation 10. Other patients judged by the attending physician to be inappropriate as subjects Patients who meet any of the following criteria will be excluded from Part 2 of the study: 1. Receiving proton pump inhibitors, H2 receptor antagonists, or rebamipide (Mucosta) 2. Have a history of hypersensitivity to any ingredients of the study drug for dyspepsia symptoms, thus precluding administration of the study treatment 3. Have severe renal disorder (creatinine clearance < 30 mL/min*1) 4. Have dyspepsia symptoms that are apparently due to causative factors other than dabigatran, such as overdrinking, overeating, abrupt stress, or concomitant medication 5. Have experienced upper gastrointestinal bleeding or gastric/duodenal ulcerative disease during Part 1 of the study 6. Have concurrent gastroesophageal reflux disease confirmed by endoscopy or X-ray performed during Part 1 of the study 7. Other patients judged by the attending physician to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Severity of dyspepsia symptoms during the observational phase of the study - Improvement rate of dyspepsia symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of patients with improvement in the severity of dyspepsia symptoms by two points or more on the GOS scale - Percentage of patients with resolution of dyspepsia symptoms (i.e., percentage of patients with improvement in the severity to a GOS scale score of 1) - Percentage of patients with improvement in dyspepsia symptoms (i.e., percentage of patients who still have their main dyspepsia symptoms, but with improvement in the severity to a GOS scale score of 1 or 2) - Post-treatment severity of dyspepsia symptoms compared with baseline (i.e., change in the GOS scale score from baseline) - Safety | — |
Countries
Japan
Outcome results
None listed