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

NCT ID: NCT04681482

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107383 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2020-11-03

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 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.

Conditions

Atrial Fibrillation; Obesity; Anticoagulants

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Apixaban Group

The cohort prescribed apixaban and diagnosed with Atrial Fibrillation

Apixaban

Intervention Type: DRUG

Anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation.

Warfarin Group

patients prescribed warfarin only diagnosed with Atrial Fibrillation.

No interventions assigned to this group

Interventions

Apixaban

Anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation.

Intervention Type: DRUG

Other Intervention Names

Eliquis

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B0661162

To obtain contact information for a study center near you, click here.

Other Identifiers

B0661162

Identifier Type: -

Identifier Source: org_study_id