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NCT03087487: ARISTOPHANES

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

Completed Last updated 25 June 2025
What this trial tests

trial in Non-Valvular Atrial Fibrillation in 466,991 participants. Completed in 8 March 2023.

Timeline
1 June 2016
Primary endpoint
26 February 2023
8 March 2023

Quick facts

Lead sponsorBristol-Myers Squibb
StatusCompleted
Study typeOBSERVATIONAL
Enrollment466,991
Start date1 June 2016
Primary completion26 February 2023
Estimated completion8 March 2023
Sites1 location across United States

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Non-Valvular Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients.
    Lip GYH, Keshishian A, Li X, Hamilton M, et al · · 2018 · cited 202× · PMID 30571400 · DOI 10.1161/strokeaha.118.020232
  2. Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With High Risk of Gastrointestinal Bleeding.
    Lip GYH, Keshishian AV, Zhang Y, Kang A, et al · · 2021 · cited 40× · PMID 34398204 · DOI 10.1001/jamanetworkopen.2021.20064
  3. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients With Active Cancer.
    Deitelzweig S, Keshishian AV, Zhang Y, Kang A, et al · · 2021 · cited 38× · PMID 34604802 · DOI 10.1016/j.jaccao.2021.06.004
  4. Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients.
    Deitelzweig S, Keshishian A, Li X, Kang A, et al · · 2019 · cited 36× · PMID 31112292 · DOI 10.1111/jgs.15956
  5. Effectiveness and Safety of Oral Anticoagulants among NVAF Patients with Obesity: Insights from the ARISTOPHANES Study.
    Deitelzweig S, Keshishian A, Kang A, Dhamane AD, et al · · 2020 · cited 24× · PMID 32481607 · DOI 10.3390/jcm9061633
  6. Apixaban 5 and 2.5 mg twice-daily versus warfarin for stroke prevention in nonvalvular atrial fibrillation patients: Comparative effectiveness and safety evaluated using a propensity-score-matched approach.
    Li X, Keshishian A, Hamilton M, Horblyuk R, et al · · 2018 · cited 23× · PMID 29373602 · DOI 10.1371/journal.pone.0191722
  7. Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus.
    Lip GYH, Keshishian AV, Kang AL, Li X, et al · · 2020 · cited 17× · PMID 32370854 · DOI 10.1016/j.mayocp.2019.05.032
  8. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data.
    Jamieson MJ, Byon W, Dettloff RW, Crawford M, et al · · 2022 · cited 7× · PMID 35570249 · DOI 10.1007/s40256-022-00524-x

Verify or expand the search:

Other recruiting trials for Non-Valvular Atrial Fibrillation

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03087487.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing