A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark

Bristol-Myers Squibb52,178 enrolled

Overview

The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments. Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.

Study Type

OBSERVATIONAL

Enrollment

52,178

Conditions

Anticoagulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The study population will consist of all patients in Denmark who meet the following criteria: * Adult (≥18 years) at time of anticoagulant initiation * Diagnosed with atrial fibrillation without recorded valvular disease * Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014). * For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases. Exclusion Criteria: * Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded

Locations (1)

Local Institution

Hellerup, Denmark

Outcomes

Primary Outcomes

The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry

Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status

Time frame: Approximately 4 years

Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry

Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure

Time frame: Approximately 4 years

Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry

Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist

Time frame: Approximately 4 years

Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry

Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors

Time frame: Approximately 4 years

Secondary Outcomes

Persistence to each OAT after initiation as monotherapy

Persistence will be defined as treatment discontinuation and will be measured by estimating the following: Discontinuation - the absence of any delivery of this product and of any other anticoagulation therapy of interest for 30 days. The date of discontinuation the OAT will be determined according to predefined algorithms to calculate treatment duration in the national prescription registry. Sensitivity analysis including a 30 and 60 day grace period will be performed to take into account incomplete adherence to treatment and dose modifications

Data from ClinicalTrials.gov

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