Overview

This trial is active, not recruiting.

Condition non-valvular atrial fibrillation
Sponsor Bristol-Myers Squibb
Collaborator IMS Health
Start date June 2014
End date November 2016
Trial size 38122 participants
Trial identifier NCT02488421, CV185-371

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)
time frame: 23 months for the UK and Germany
Compare persistence rates across oral anticoagulant therapies
time frame: 23 months for the UK and Germany, 25 months for France

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2
Description Actual number of patients enrolled for UK : 15242 patients Actual number of patients enrolled for Germany : 22880 patients
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.