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

NCT02488421 | Completed

• 1 other identifier: CV185-371
• Study Type: observational
• Target: 38,122
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

Patient treated with Apixaban

Patient treated with Rivaroxaban

Patient treated with Dabigatran

Patient treated with vitamin K antagonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• IMS Health: collaborator
• OXON Epidemiology: collaborator

Related Publications (2)

• 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.

  PMID: 29398546 DERIVED

• 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.

  PMID: 27678530 DERIVED

Related Links

• Investigator Inquiry form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12