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Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Rivaroxaban
Drug: Dabigatran
Drug: Warfarin
Drug: Apixaban

Study type

Observational

Funder types

Industry

Identifiers

NCT02754154
CV185-433

Details and patient eligibility

About

The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.

Enrollment

321,182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients ≥18 years old as of the index date
  • At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
  • At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study

Exclusion criteria

  • Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
  • Patients with any evidence of pregnancy at any time during the baseline will be excluded

Trial design

321,182 participants in 4 patient groups

Patients using Warfarin
Description:
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin
Treatment:
Drug: Warfarin
Patients using Apixaban
Description:
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban
Treatment:
Drug: Apixaban
Patients using Dabigatran
Description:
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran
Treatment:
Drug: Dabigatran
Patients using Rivaroxaban
Description:
Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban
Treatment:
Drug: Rivaroxaban

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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