Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation

NCT ID: NCT03002740

Last Updated: 2018-10-10

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WITHDRAWN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

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

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In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.

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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NVAF patients newly prescribed apixaban

No interventions assigned to this group

NVAF patients newly prescribed rivaroxaban

No interventions assigned to this group

NVAF patients newly prescribed dabigatran

No interventions assigned to this group

NVAF patients newly prescribed VKA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
2. Are ≥ 18 years of age at index date
3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
4. Have a record of AF on or ever prior to index date

Exclusion Criteria

1. Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
2. Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
3. Have more than 1 OAC exposure which starts on the same date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

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

Related Links

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Other Identifiers

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CV185-491

Identifier Type: -

Identifier Source: org_study_id

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