Japanese Pradaxa PMS, Long Term

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Prazaxa® Capsules

• Registration Number: NCT03175198
• Lead Sponsor: Boehringer Ingelheim

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 Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2017-07-05
• Primary Completion: 2020-12-21
• Study Completion: 2021-01-12
• Results First Submitted: 2021-12-20
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Results First Posted: 2022-04-06
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5660

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with nonvalvular atrial fibrillation (NVAF)	Prazaxa® Capsules	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)	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.

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd; 🇯🇵 Tokyo, Japan