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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

Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03189069
Enrollment
36000
Registered
2017-06-16
Start date
2016-10-06
Completion date
2017-05-31
Last updated
2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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.

Interventions

DRUGApixaban

Treatment for NVAF patients

DRUGDabigatran

Treatment for NVAF patients

DRUGRivaroxaban

Treatment for NVAF patients

DRUGWarfarin

Treatment for NVAF patients

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Major bleeding36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026