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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02591732
Collaborator
University Hospital, Gentofte, Copenhagen (Other)
52,178
Enrollment
1
Location
10
Duration (Months)
5224.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    52178 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    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 Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patient treated with Apixaban
    Patient treated with Rivaroxaban
    Patient treated with Dabigatran
    Patient treated with vitamin K antagonists

    Outcome Measures

    Primary Outcome Measures

    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 [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 [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 [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 [Approximately 4 years]

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

    Secondary Outcome Measures

    1. Persistence to each OAT after initiation as monotherapy [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 [Approximately 4 years]

      Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist

    3. Clinically relevant bleeding events after initiating an OAT as monotherapy [Approximately 4 years]

    4. Bleeding events requiring hospitalization in patients treated with apixaban [Approximately 4 years]

    5. Bleeding events requiring out-patient care in patients treated with apixaban [Approximately 4 years]

    6. Bleeding events requiring hospitalization in patients treated with rivaroxaban [Approximately 4 years]

    7. Bleeding events requiring out-patient care in patients treated with rivaroxaban [Approximately 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Hellerup Denmark 2900

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • University Hospital, Gentofte, Copenhagen

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02591732
    Other Study ID Numbers:
    • CV185-377
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    May 18, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 18, 2016