N/A
N=53,969
Medical Need of OAC Reversal
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03254147 ↗Enrolled (actual)
53,969
Serious AEs
—
Results posted
Mar 2019
Primary outcome: Primary: The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. — 14; 35; 84 Number of Patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- warfarin (Drug); dabigatran (Drug); Apixaban (Drug); Edoxaban (Drug); Rivaroxaban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. |
14; 35; 84 | — |
| SECONDARY The Number of Patients With Cardiac Tamponade and Pericardiocentesis. |
1 | — |
Summary
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
Eligibility Criteria
Inclusion Criteria
->18 year old non-valvular atrial fibrillation (NVAF) patients
- Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
- Patients with confirmed date of initiation of OACs
- Patients with a minimum of 6 months of enrolment data prior to index date
- Has an index date between 14th of March 2011 to 30 June, 2016
Exclusion Criteria
- Patients receiving two or more oral anti-coagulants at the same time at index date
- Patients with prescriptions of index treatment in the 6 months prior to index date
- Patients without enrolment period of at least six month in the database
Data sourced from ClinicalTrials.gov (NCT03254147). 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.