Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

NCT ID: NCT02754154

Last Updated: 2022-05-09

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

321182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-26

Brief Summary

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The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients using Warfarin

Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin

Warfarin

Intervention Type DRUG

Patients using Apixaban

Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban

Apixaban

Intervention Type DRUG

Patients using Dabigatran

Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran

Dabigatran

Intervention Type DRUG

Patients using Rivaroxaban

Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban

Rivaroxaban

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Dabigatran

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 years old as of the index date
* At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
* At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study

Exclusion Criteria

* Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
* Patients with any evidence of pregnancy at any time during the baseline will be excluded
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

Related Links

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Other Identifiers

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CV185-433

Identifier Type: -

Identifier Source: org_study_id

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