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Completed

NCT Number: NCT02488421

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Actual number of patients enrolled for UK : 15242 patients

Actual number of patients enrolled for Germany : 22880 patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants

    Time frame: 23 months for the UK and Germany, 25 months for France

  2. 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

    Time frame: 23 months for the UK and Germany, 25 months for France

  3. Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)

    Time frame: 23 months for the UK and Germany

  4. Compare persistence rates across oral anticoagulant therapies

    Time frame: 23 months for the UK and Germany, 25 months for France

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • IMS Health
  • OXON Epidemiology

Registry information

Official study title

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

Acronym: REACT-AF2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2015
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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