Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

NCT ID: NCT03508258

Last Updated: 2022-06-30

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-01

Brief Summary

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Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England

Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with NVAF starting Apixaban

Non-interventional

Intervention Type OTHER

Non-interventional

Participants with NVAF starting Warfarin

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-interventional

Non-interventional

Intervention Type OTHER

Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
* Incident prescription of an oral anticoagulant (index date)
* Patients with at least one year of computerized data prior to index date

Exclusion Criteria

* Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
* Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Bethesda, Maryland, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV185-664

Identifier Type: -

Identifier Source: org_study_id

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