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Real-world Dosing Patterns of Rivaroxaban in the United States

Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03242278
Enrollment
12507
Registered
2017-08-08
Start date
2016-02-12
Completion date
2016-03-01
Last updated
2023-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation (NVAF), Prevention, Stroke

Brief summary

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).

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of NVAF patients receiving 20 mg RivaroxabanAt baseline
Number of NVAF patients receiving 15 mg RivaroxabanAt baseline

Secondary

MeasureTime frame
Baseline renal functionAt baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026