Skip to content

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

Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03087487
Acronym
ARISTOPHANES
Enrollment
466991
Registered
2017-03-22
Start date
2016-06-01
Completion date
2023-03-08
Last updated
2025-06-25

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

Conditions

Non-Valvular Atrial Fibrillation

Brief summary

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.

Interventions

None listed

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

1. 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 2. Patients 18 years old or older as of the index date 3. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim 4. At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion criteria

1. Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date 2. Evidence of pregnancy during the study period 3. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period 4. Had more than 1 oral anticoagulant claim on the index date

Design outcomes

Primary

MeasureTime frame
Time to first major bleeding eventUp to 33 months
Time to first stroke/systemic embolism (SE) eventUp to 33 months

Secondary

MeasureTime frame
Major bleeding-related medical costsUp to 33 months
Stroke/SE-related medical costsUp to 33 months
All-cause Healthcare costsUp to 33 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026