Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38,122
- Primary Endpoint
- Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)
Study Overview
Brief Summary
The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.
Detailed Description
Actual number of patients enrolled for UK : 15242 patients
Actual number of patients enrolled for Germany : 22880 patients
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have an apixaban, rivaroxaban, dabigatran or VKA prescription during the study period
- •Are ≥18 years old at index date
- •Have ≥12 months of computerised medical data prior to index date
- •Have a record of AF on or ever prior to index date (index OAC prescription)
Exclusion Criteria
- •Have a record for a valvular condition (ie, rheumatic valvular disease and prosthetic valves) on or ever prior to index date
- •Have a history (ever prior to index date) of the Oral anticoagulant (OACs) which are prescribed during the study period
Outcomes
Primary Outcomes
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)
Time Frame: 23 months for the UK and Germany, 25 months for France
We defined non-persistence in the databases as the absence of index prescription for twice the median prescription duration; and calculated cumulative incidence (95% CIs) of persistence at the end of follow-up and at different time points after treatment initiation (3, 6, and 12 months)
Secondary Outcomes
- Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)(23 months for the UK and Germany)
- Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants(23 months for the UK and Germany, 25 months for France)
- Clinical characteristics (History of bleeding, myocardial infarction, stroke, Thromboembolism, congestive heart failure, vascular disease, hypertension, CHA2DS2-VASc score, HAS-BLED score, etc) of patients with newly prescribed oral anticoagulants(23 months for the UK and Germany, 25 months for France)
- Compare persistence rates across oral anticoagulant therapies(23 months for the UK and Germany, 25 months for France)