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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban; Drug: Dabigatran; Drug: Apixaban; Drug: Warfarin

• Registration Number: NCT03189069
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-06
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed rivaroxaban	Rivaroxaban	-
Patients prescribed dabigatran	Dabigatran	-
Patients prescribed apixaban	Apixaban	-
Patients prescribed warfarin	Warfarin	-

Primary Outcome Measures

Name	Time	Method
Major bleeding	36 months