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OpenTrials
Completed

NCT Number: NCT03087487

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Ann Arbor, Michigan, 48104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to first major bleeding event

    Time frame: Up to 33 months

  2. Time to first stroke/systemic embolism (SE) event

    Time frame: Up to 33 months

Secondary outcomes

  1. Major bleeding-related medical costs

    Time frame: Up to 33 months

  2. Stroke/SE-related medical costs

    Time frame: Up to 33 months

  3. All-cause Healthcare costs

    Time frame: Up to 33 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: ARISTOPHANES

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2017
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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