Real-world Dosing Patterns of Rivaroxaban in the United States

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

12507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-12

Study Completion Date

2016-03-01

Brief Summary

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The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban.

The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).

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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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NVAF patients receiving 20 mg rivaroxaban

NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

As prescribed by treating physicians

NVAF patients receiving 15 mg rivaroxaban

NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)

Rivaroxaban (Xarelto, BAY59-7939)

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

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 International Classification of Disease 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 score ≥2 during the 180 days prior to index rivaroxaban use baseline period
* Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No