The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
- Registration Number
- NCT04198844
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Apixaban user apixaban - Warfarin user warfarin -
- Primary Outcome Measures
Name Time Method Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism 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) Intake period is from July 1, 2015 to Nov 30, 2016.
- Secondary Outcome Measures
Name Time Method Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding 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) Intake period is from July 1, 2015 to Nov 30, 2016.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇰🇷Seoul, Korea, Republic of