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Completed

NCT Number: NCT02591732

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

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.

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Approximately 4 years

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

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

    Time frame: Approximately 4 years

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

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

    Time frame: Approximately 4 years

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

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

    Time frame: Approximately 4 years

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

Secondary outcomes

  1. Persistence to each OAT after initiation as monotherapy

    Time frame: 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

  2. Persistence between apixaban and other OAT

    Time frame: Approximately 4 years

    Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist

  3. Clinically relevant bleeding events after initiating an OAT as monotherapy

    Time frame: Approximately 4 years

  4. Bleeding events requiring hospitalization in patients treated with apixaban

    Time frame: Approximately 4 years

  5. Bleeding events requiring out-patient care in patients treated with apixaban

    Time frame: Approximately 4 years

  6. Bleeding events requiring hospitalization in patients treated with rivaroxaban

    Time frame: Approximately 4 years

  7. Bleeding events requiring out-patient care in patients treated with rivaroxaban

    Time frame: Approximately 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • University Hospital, Gentofte, Copenhagen

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2015
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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