- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03087487
Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation (ARISTOPHANES)
December 5, 2023 updated by: Bristol-Myers Squibb
Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
466991
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
NVAF patients who were initiators of warfarin or apixaban or dabigatran or rivaroxaban treatment from 01-Jan-2013 through 30-Sep-2015.
All patients who have at least 1 year of baseline data available and no prior OAC use will be included in this study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NVAF patients on Warfarin
NVAF patients newly initiated with Warfarin.
Non-Interventional.
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NVAF patients on Apixaban
NVAF patients newly initiated on Apixaban.
Non-Interventional.
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NVAF patients on Dabigatran
NVAF patients newly initiated with Dabigatran.
Non-Interventional.
|
NVAF patients on Rivaroxaban
NVAF patients newly initiated with Rivaroxaban.
Non-Interventional.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first major bleeding event
Time Frame: Up to 33 months
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Up to 33 months
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Time to first stroke/systemic embolism (SE) event
Time Frame: Up to 33 months
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Up to 33 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major bleeding-related medical costs
Time Frame: Up to 33 months
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Up to 33 months
|
Stroke/SE-related medical costs
Time Frame: Up to 33 months
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Up to 33 months
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All-cause Healthcare costs
Time Frame: Up to 33 months
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Up to 33 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lip GYH, Keshishian AV, Kang AL, Li X, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Nadkarni A, Pan X, Di Fusco M, Garcia Reeves AB, Yuce H, Deitelzweig SB. Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus. Mayo Clin Proc. 2020 May;95(5):929-943. doi: 10.1016/j.mayocp.2019.05.032.
- Lip GYH, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Baser O, Deitelzweig S. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients. Stroke. 2018 Dec;49(12):2933-2944. doi: 10.1161/STROKEAHA.118.020232. Erratum In: Stroke. 2020 Feb;51(2):e44. Stroke. 2020 Apr;51(4):e71.
- Li X, Keshishian A, Hamilton M, Horblyuk R, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Lip GYH, Deitelzweig S. 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. PLoS One. 2018 Jan 26;13(1):e0191722. doi: 10.1371/journal.pone.0191722. eCollection 2018.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
September 30, 2015
Study Completion (Actual)
March 8, 2023
Study Registration Dates
First Submitted
March 17, 2017
First Submitted That Met QC Criteria
March 17, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV185-543
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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