Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02690155

Acronym

RIVA-F

Enrollment

38831

Registered

2016-02-24

Start date

2016-02-12

Completion date

2016-03-01

Last updated

2017-04-05

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

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

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

As prescribed by treating physicians

DRUGVKA (Vitamin K antagonist)

As prescribed by treating physicians

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of Hospitalization Events (composite endpoint)	Within 2 years of starting treatment

Countries

United States

Outcome results

None listed

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