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Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist (PIXI-F)

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ClinicalTrials.gov Identifier: NCT02687854
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Apixaban Drug: Vitamin K antagonist

Study Type : Observational
Actual Enrollment : 18591 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Comparative Effectiveness of Apixaban Versus VKA
Actual Study Start Date : February 12, 2016
Primary Completion Date : March 1, 2016
Study Completion Date : March 1, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Non-valvular atrial fibrillation patients who were initiated on apixaban for stroke prevention
Drug: Apixaban
As prescribed by treating physicians
Vitamin K antagonist
Non-valvular atrial fibrillation patients who were initiated on Vitamin K antagonist for stroke prevention
Drug: Vitamin K antagonist
As prescribed by treating physicians

Primary Outcome Measures :
  1. Incidence of Hospitalization Events (composite endpoint) [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation (NVAF)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687854

United States, New York
New York, New York, United States
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02687854     History of Changes
Other Study ID Numbers: 18731
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Bayer:
Non-valvular atrial fibrillation (NVAF)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Growth Substances
Physiological Effects of Drugs
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents