Study Completed

Atrial Fibrillation

Bayer Identifier:

18731

ClinicalTrials.gov Identifier:

NCT02687854

EudraCT Number:

Not Available

EU CT Number:

Not Available

Real-world comparative effectiveness of Apixaban versus Vitamin K antagonist

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial summary

Enrollment Goal

18591

Trial Dates

February 2016 - March 2016

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		New York, United States

Primary Outcome

Incidence of Hospitalization Events (composite endpoint)
Time Frame:
Up to 2 years
Safety Issue:
Yes

Trial design

Real-world comparative effectiveness of Apixaban versus VKA

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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