Japanese Pradaxa PMS, Long Term

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Prazaxa® Capsules

Study type: Observational

Funder types: Industry

Identifiers

NCT03175198

1160-0284

Details and patient eligibility

About

The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

Full 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

Enrollment: 5,660 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

• None

Trial design

5,660 participants in 1 patient group

Patients with nonvalvular atrial fibrillation (NVAF)

Description:

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.

Treatment:

Drug: Prazaxa® Capsules