check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18733

ClinicalTrials.gov Identifier:

NCT03242278

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real-world dosing patterns of rivaroxaban in the United States

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
12507
Trial Dates
February 2016 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New York, United States

Primary Outcome

  • Number of NVAF patients receiving 20 mg Rivaroxaban
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Number of NVAF patients receiving 15 mg Rivaroxaban
    date_rangeTime Frame:
    At baseline

Secondary Outcome

  • Baseline renal function
    date_rangeTime Frame:
    At baseline

Trial design

Real-world dosing patterns of rivaroxaban in the United States (RIVA-D)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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