N/A
N=6,443
Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01491178 ↗Enrolled (actual)
6,443
Serious AEs
9.6%
Results posted
Jan 2018
Primary outcome: Primary: Frequency (Percentage) of Participants With Adverse Drug Reactions — 28.2 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prazaxa (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency (Percentage) of Participants With Adverse Drug Reactions |
28.2 | — |
| SECONDARY Incidences of Stroke and Systemic Embolism (SEE) |
1.27 | — |
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).
Eligibility Criteria
Inclusion criteria
- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.
Exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT01491178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.