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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02488421
Acronym
REACT-AF2
Enrollment
38122
Registered
2015-07-02
Start date
2014-06-30
Completion date
2016-07-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-valvular Atrial Fibrillation

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

Interventions

None listed

Sponsors

IMS Health
CollaboratorOTHER
OXON Epidemiology
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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 FranceWe 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

MeasureTime frame
Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants23 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 anticoagulants23 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 therapies23 months for the UK and Germany, 25 months for France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026