Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2

Completed

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT02488421
• Lead Sponsor: Bristol-Myers Squibb

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38122

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)	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 Outcome Measures

Name	Time	Method
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