Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

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

38831 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 rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting

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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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Rivaroxaban

NVAF patients who were initiated on rivaroxaban for stroke prevention

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

As prescribed by treating physicians

VKA (Vitamin K antagonist)

NVAF patients who were initiated on VKA for stroke prevention

VKA (Vitamin K antagonist)

Intervention Type DRUG

As prescribed by treating physicians

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

Intervention Type DRUG

VKA (Vitamin K antagonist)

As prescribed by treating physicians

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No