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

Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2

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.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation

Detailed Description

Actual number of patients enrolled for UK : 15242 patients

Actual number of patients enrolled for Germany : 22880 patients

• Study Type: Observational
• Enrollment (Actual): 38122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Patient treated with Apixaban
Patient treated with Rivaroxaban
Patient treated with Dabigatran
Patient treated with vitamin K antagonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)	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)	23 months for the UK and Germany, 25 months for France

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)	23 months for the UK and Germany
Compare persistence rates across oral anticoagulant therapies	23 months for the UK and Germany, 25 months for France

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: IMS Health; OXON Epidemiology

Publications and helpful links

General Publications

• Collings SL, Vannier-Moreau V, Johnson ME, Stynes G, Lefevre C, Maguire A, Asmar J, Bizouard G, Duhot D, Mouquet F, Fauchier L. Initiation and continuation of oral anticoagulant prescriptions for stroke prevention in non-valvular atrial fibrillation: A cohort study in primary care in France. Arch Cardiovasc Dis. 2018 May;111(5):370-379. doi: 10.1016/j.acvd.2017.10.003. Epub 2018 Feb 3.
• Johnson ME, Lefevre C, Collings SL, Evans D, Kloss S, Ridha E, Maguire A. Early real-world evidence of persistence on oral anticoagulants for stroke prevention in non-valvular atrial fibrillation: a cohort study in UK primary care. BMJ Open. 2016 Sep 26;6(9):e011471. doi: 10.1136/bmjopen-2016-011471.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CV185-371