Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Prazaxa

• Registration Number: NCT01491178
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Primary Completion: 2016-08-02
• Study Completion: 2016-08-02
• Status Verified: 2017-07
• Results First Submitted: 2017-07-26
• Results First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Results First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6772

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with NVAF	Prazaxa	-

Primary Outcome Measures

Name	Time	Method
Frequency (Percentage) of Participants With Adverse Drug Reactions	Up to 104 weeks from first administration of study drug	Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".

Secondary Outcome Measures

Name	Time	Method
Incidences of Stroke and Systemic Embolism (SEE)	Up to 104 weeks from first administration of study drug	Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.

Trial Locations

Locations (1164)

Boehringer Ingelheim Investigational Site 1; 🇯🇵 Abashiri, Hokkaido, Japan

Boehringer Ingelheim Investigational Site 287; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 288; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 289; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 290; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 291; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 292; 🇯🇵 Adachi,Tokyo, Japan

Boehringer Ingelheim Investigational Site 1141; 🇯🇵 Aira,Kagoshima, Japan

Boehringer Ingelheim Investigational Site 622; 🇯🇵 Aisai,Aichi, Japan

Boehringer Ingelheim Investigational Site 111; 🇯🇵 Aizuwakamatsu,Fukushima, Japan

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Boehringer Ingelheim Investigational Site 1

🇯🇵Abashiri, Hokkaido, Japan