A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

NCT ID: NCT03189069

Last Updated: 2019-01-30

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

COMPLETED

Total Enrollment

36000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-06

Study Completion Date

2017-05-31

Brief Summary

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The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.

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 prescribed apixaban

Apixaban

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed dabigatran

Dabigatran

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed rivaroxaban

Rivaroxaban

Intervention Type DRUG

Treatment for NVAF patients

Patients prescribed warfarin

Warfarin

Intervention Type DRUG

Treatment for NVAF patients

Interventions

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Apixaban

Treatment for NVAF patients

Intervention Type DRUG

Dabigatran

Treatment for NVAF patients

Intervention Type DRUG

Rivaroxaban

Treatment for NVAF patients

Intervention Type DRUG

Warfarin

Treatment for NVAF patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)
* Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)
* Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date
* Had at least 1 medical claim for atrial fibrillation any time before or on index date

Exclusion Criteria

* Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period
* Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period
* Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period
* Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date
* Had claims for a diagnosis or procedure code for reversible atrial fibrillation
* Had medical claims indicating pregnancy during the study period
* Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period
* Had \> 1 oral anticoagulant prescription claim on the index date
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

Related Links

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Other Identifiers

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CV185-583

Identifier Type: -

Identifier Source: org_study_id

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