Real-world Dosing Patterns of Rivaroxaban in the United States

Bayer

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type

Observational

Funder types

Industry

Identifiers

NCT03242278

18733

XA1511US (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

12,507 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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