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 Squibb (BMS)

Status: Completed

Conditions: Anticoagulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02591732

CV185-377

Details and patient eligibility

About

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.

Enrollment: 52,178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52,178 participants in 4 patient groups

Patient treated with Apixaban

Patient treated with Rivaroxaban

Patient treated with Dabigatran

Patient treated with vitamin K antagonists