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

Atrial Fibrillation Clinical Trial

Official title:

The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04198844
• Other study ID #: B0661126
• Status: Withdrawn
• Start date: November 18, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Osteoporosis

Intervention

Drug:
• warfarin
warfarin user
• apixaban
apixaban user

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism	Intake period is from July 1, 2015 to Nov 30, 2016.	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	Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding	Intake period is from July 1, 2015 to Nov 30, 2016.	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)

External Links

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