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

NCT ID: NCT02591732

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anticoagulation

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient treated with Apixaban

No interventions assigned to this group

Patient treated with Rivaroxaban

No interventions assigned to this group

Patient treated with Dabigatran

No interventions assigned to this group

Patient treated with vitamin K antagonists

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Hellerup, , Denmark

Site Status

Countries

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Denmark

Related Links

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Other Identifiers

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CV185-377

Identifier Type: -

Identifier Source: org_study_id

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