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

Completed

• Conditions: Anticoagulation

• Registration Number: NCT02591732
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-30
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52178

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.

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Exclusion Criteria

• Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry	Approximately 4 years	Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist
The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry	Approximately 4 years	Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status
Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry	Approximately 4 years	Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure
Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry	Approximately 4 years	Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors

Secondary Outcome Measures

Name	Time	Method
Bleeding events requiring hospitalization in patients treated with rivaroxaban	Approximately 4 years
Persistence between apixaban and other OAT	Approximately 4 years	Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist
Clinically relevant bleeding events after initiating an OAT as monotherapy	Approximately 4 years
Bleeding events requiring hospitalization in patients treated with apixaban	Approximately 4 years
Bleeding events requiring out-patient care in patients treated with apixaban	Approximately 4 years
Persistence to each OAT after initiation as monotherapy	Approximately 4 years	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
Bleeding events requiring out-patient care in patients treated with rivaroxaban	Approximately 4 years

Trial Locations

Locations (1)

Local Institution; 🇩🇰 Hellerup, Denmark