Status:
COMPLETED
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
Lead Sponsor:
Pfizer
Conditions:
Atrial Fibrillation
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atri...
Eligibility Criteria
Inclusion
- Obese or severely obese.
- Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
- Individuals ≥18 years old as of the index date.
- Had 6 months continuous health plan enrollment with medical benefits (Parts A \& B) for at least 6 months pre-index date (baseline period).
- At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.
- Had body weight or BMI value reported within ±6 months of the index date.
Exclusion
- Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
- Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
- Were pregnant during the study period.
- Had an OAC prescription during the 6 months pre-index date.
- Had follow-up time equal to 0 days.
- Had more than one OAC on the index date.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
107383 Patients enrolled
Trial Details
Trial ID
NCT04681482
Start Date
November 2 2020
End Date
November 3 2020
Last Update
May 22 2023
Active Locations (1)
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1
Pfizer
New York, New York, United States, 10012