Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare

Completed

Conditions studied: Atrial Fibrillation, Obesity, Anticoagulants

In brief

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 atrial fibrillation (NVAF) who initiate therapy with OACs (oral anti-coagulants). The aim of this study is to compare all DOACs (direct oral anti-coagulants) to warfarin. However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.

Key facts

Study ID

NCT04681482

Run by

Pfizer

People needed

107383

Starts

2020-11-02

Expected to finish

2020-11-03

Last updated by the study team

2023-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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