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

Anticoagulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591732
• Other study ID #: CV185-377
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: May 17, 2016
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country Name: None
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52178
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation

Locations

Country	Name	City	State
Denmark	Local Institution	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Persistence to each OAT after initiation as monotherapy	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	Approximately 4 years	No
Secondary	Persistence between apixaban and other OAT	Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist	Approximately 4 years	No
Secondary	Clinically relevant bleeding events after initiating an OAT as monotherapy		Approximately 4 years	Yes
Secondary	Bleeding events requiring hospitalization in patients treated with apixaban		Approximately 4 years	Yes
Secondary	Bleeding events requiring out-patient care in patients treated with apixaban		Approximately 4 years	Yes
Secondary	Bleeding events requiring hospitalization in patients treated with rivaroxaban		Approximately 4 years	Yes
Secondary	Bleeding events requiring out-patient care in patients treated with rivaroxaban		Approximately 4 years	Yes

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form