Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)

Not Applicable

• Conditions: on-valvular atrial fibrillation

• Registration Number: JPRN-UMIN000007579
• Lead Sponsor: Committee on Proper Use of Anticoagulant Therapies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-27
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified