Clinical trial NCT02591732: A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark
Official title: A Nation-wide Registry Study of Patients With Non-valvular Atrial Fibrillation Initiating Anticoagulation Therapies in the Early Period Follow Apixaban Marketing in Denmark: Patient Characteristics, Treatment Patterns, and Early Bleeding Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2015-10-30
Enrollment: 52178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject must be over 18 years of age, male and females are eligible

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.


Eligibility criteria: 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

Primary outcomes:
measure: The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry
timeFrame: Approximately 4 years
measure: Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry
timeFrame: Approximately 4 years
measure: Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
timeFrame: Approximately 4 years
measure: Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
timeFrame: Approximately 4 years
Secondary outcomes:
measure: Persistence to each OAT after initiation as monotherapy
timeFrame: Approximately 4 years
measure: Persistence between apixaban and other OAT
timeFrame: Approximately 4 years
measure: Clinically relevant bleeding events after initiating an OAT as monotherapy
timeFrame: Approximately 4 years
measure: Bleeding events requiring hospitalization in patients treated with apixaban
timeFrame: Approximately 4 years
measure: Bleeding events requiring out-patient care in patients treated with apixaban
timeFrame: Approximately 4 years
measure: Bleeding events requiring hospitalization in patients treated with rivaroxaban
timeFrame: Approximately 4 years
measure: Bleeding events requiring out-patient care in patients treated with rivaroxaban
timeFrame: Approximately 4 years
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: