Status:

COMPLETED

Real-world Dosing Patterns of Rivaroxaban in the United States

Lead Sponsor:

Bayer

Collaborating Sponsors:

Janssen Research & Development, LLC

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18+ years

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. ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 12 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2016

Estimated Enrollment :

12507 Patients enrolled

Trial Details

Trial ID

NCT03242278

Start Date

February 12 2016

End Date

March 1 2016

Last Update

June 28 2023

Active Locations (1)

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1

New York, New York, United States

Real-world Dosing Patterns of Rivaroxaban in the United States | DecenTrialz