Study Completed

Atrial Fibrillation

Bayer Identifier:

18734

ClinicalTrials.gov Identifier:

NCT02690155

EudraCT Number:

Not Available

EU CT Number:

Not Available

Real-world comparative effectiveness of Rivaroxaban versus VKA

Trial purpose

To obtain a better understanding on the comparative effectiveness of rivaroxaban 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(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient
claims with ICD(International Classification of Disease)-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 score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65–74 years; Sc: Sex category)
Exclusion Criteria
-Patients <18 years of age
-Patients with valvular AF (Atrial fibrillation)
-Pregnancy
-Malignant cancers
-Transient cause of AF
-Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis)
-Patients with major surgery defined as hip or knee replacement
-Prescriptions of oral anticoagulants (OACs) (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
--Fatal bleeding
--Fatal Stroke/Myocardial infarction
--Intracranial hemorrhage
--Ischemic stroke
--Myocardial infarction

Trial summary

Enrollment Goal

38831

Trial Dates

February 2016 - March 2016

Phase

N/A

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		New York, United States

Primary Outcome

Incidence of Hospitalization Events (composite endpoint)
Time Frame:
Within 2 years of starting treatment
Safety Issue:
Yes

Trial design

Real-world comparative effectiveness of Rivaroxaban 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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