Clinical trial NCT02488421: Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2
Official title: Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: IMS Health
name: OXON Epidemiology
First posted: 2015-07-02
Enrollment: 38122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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

Eligibility criteria: 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

Primary outcomes:
measure: Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)
timeFrame: 23 months for the UK and Germany, 25 months for France
Secondary outcomes:
measure: Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants
timeFrame: 23 months for the UK and Germany, 25 months for France
measure: 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
timeFrame: 23 months for the UK and Germany, 25 months for France
measure: Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)
timeFrame: 23 months for the UK and Germany
measure: Compare persistence rates across oral anticoagulant therapies
timeFrame: 23 months for the UK and Germany, 25 months for France
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.