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OpenTrials
Completed

NCT Number: NCT03242278

Real-world Dosing Patterns of Rivaroxaban in the United States

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by treating physicians

Primary outcomes

  1. Number of NVAF patients receiving 20 mg Rivaroxaban

    Time frame: At baseline

  2. Number of NVAF patients receiving 15 mg Rivaroxaban

    Time frame: At baseline

Secondary outcomes

  1. Baseline renal function

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2017
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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