Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 5,660
- Locations
- 1
- Primary Endpoint
- Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Study Overview
Brief Summary
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
Detailed Description
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with nonvalvular atrial fibrillation (NVAF)
Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
Intervention: Prazaxa® Capsules (Drug)
Outcomes
Primary Outcomes
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Time Frame: From baseline till the last administration + 6 days. Up to 364 days.
Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places.
Secondary Outcomes
No secondary outcomes reported