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

Non-valvular Atrial Fibrillation Clinical Trial

— REACT-AF2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488421
• Other study ID #: CV185-371
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: December 19, 2016
• Start date: June 2014
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country Name: NONE
• Study type: Observational

Clinical Trial 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.

Description:

Actual number of patients enrolled for UK : 15242 patients

Actual number of patients enrolled for Germany : 22880 patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38122
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	IMS Health, Oxon Epidemiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)		23 months for the UK and Germany	No
Secondary	Compare persistence rates across oral anticoagulant therapies		23 months for the UK and Germany, 25 months for France	No

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form