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

N/AWithdrawnNCT04198844

Pfizer

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

Interventions

warfarinDRUG

warfarin user

apixabanDRUG

apixaban user

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Pfizer Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism

Intake period is from July 1, 2015 to Nov 30, 2016.

Time frame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)

Secondary Outcomes

Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding

Intake period is from July 1, 2015 to Nov 30, 2016.

Time frame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period (the index date- Nov 30, 2016 or outcomes whichever comes first)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.