Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation (ARISTOPHANES)

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Non-Valvular Atrial Fibrillation

Study type

Observational

Funder types

Industry

Identifiers

NCT03087487

CV185-543

Details and patient eligibility

About

The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.

Enrollment

466,991 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
Patients 18 years old or older as of the index date
At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion criteria

Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
Evidence of pregnancy during the study period
Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
Had more than 1 oral anticoagulant claim on the index date