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The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study

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Pfizer

Status

Withdrawn

Conditions

Atrial Fibrillation

Treatments

Drug: apixaban
Drug: warfarin

Study type

Observational

Funder types

Industry

Identifiers

NCT04198844
B0661126

Details and patient eligibility

About

Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Therefore, in real world, these risk factors and co-morbidities are commonly considered when it comes to prescribe anticoagulant in atrial fibrillation patients. Recent study even reported that comorbid atrial fibrillation in patients with osteoporosis might be associated with an increased risk of bone fracture and death after fracture. Because there have been very few data about the effectiveness/safety of anticoagulant among non-valvular atrial fibrillation with prior osteoporosis/fracture, this study is planned to provide real-world evidences for this specific type of non-valvular atrial fibrillation patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 18 years or older on the index date
  • Patients had ≥1 medical claim for atrial fibrillation with at least one hospitalization or at least two outpatient visits during the reference period

Exclusion criteria

  • Patients with valvular atrial fibrillation or transient atrial fibrillation
  • Having ≥ 2 types of oral anticoagulant on the index date
  • who have contraindications to oral anticoagulant
  • confounder factors related to the outcome (osteoporotic fractures)

Trial design

0 participants in 2 patient groups

Warfarin user
Treatment:
Drug: warfarin
Apixaban user
Treatment:
Drug: apixaban

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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