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

NCT04198844 | Withdrawn

• 1 other identifier: B0661126
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Warfarin user

Drug: warfarin

Apixaban user

Drug: apixaban

Interventions

warfarin DRUG

warfarin user

Warfarin user

apixaban DRUG

apixaban user

Apixaban user

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-valvular atrial fibrillation patients with warfarin or apixaban user

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Seoul, 04631, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin; apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 13, 2019
• Study Start: November 18, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)