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

NCT02591732 | Completed

• 1 other identifier: CV185-377
• Study Type: observational
• Target: 52,178
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Approximately 4 years

Secondary Outcomes (7)

• Persistence to each OAT after initiation as monotherapy

  Approximately 4 years

• Persistence between apixaban and other OAT

  Approximately 4 years

• 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

Study Arms (4)

Patient treated with Apixaban

Patient treated with Rivaroxaban

Patient treated with Dabigatran

Patient treated with vitamin K antagonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject must be over 18 years of age, male and females are eligible

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Local Institution

Hellerup, 2900, Denmark

Location

Related Links

• Investigator Inquiry form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 30, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

DK (1)