Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist

Atrial Fibrillation Clinical Trial

— PIXI-F  

Official title:

Real-world Comparative Effectiveness of Apixaban Versus VKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687854
• Other study ID #: 18731
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: April 4, 2017
• Start date: February 12, 2016
• Est. completion date: March 1, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18591
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion

• Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics

• CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age =75 years; D:

Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score =2 during the 180 days prior to index apixaban use baseline period

Exclusion Criteria:

• Patients <18 years of age

• Patients with valvular AF (Atrial fibrillation)

• Pregnancy

• Malignant cancers

• Transient cause of AF

• Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))

• Patients with major surgery defined as hip or knee replacement

• Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date

• Prescription of more than one OAC on the index date

• Patient with any of the events defined in the composite endpoint

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
As prescribed by treating physicians
• Vitamin K antagonist
As prescribed by treating physicians

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hospitalization Events (composite endpoint)		Up to 2 years

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