Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist

NCT ID: NCT02687854

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18591 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-12

Study Completion Date

2016-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Apixaban

Non-valvular atrial fibrillation patients who were initiated on apixaban for stroke prevention

Apixaban

Intervention Type DRUG

As prescribed by treating physicians

Vitamin K antagonist

Non-valvular atrial fibrillation patients who were initiated on Vitamin K antagonist for stroke prevention

Vitamin K antagonist

Intervention Type DRUG

As prescribed by treating physicians

Interventions

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Apixaban

As prescribed by treating physicians

Intervention Type DRUG

Vitamin K antagonist

As prescribed by treating physicians

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18731

Identifier Type: -

Identifier Source: org_study_id

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