Real-world Dosing Patterns of Rivaroxaban in the United States

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242278
• Other study ID #: 18733
• Secondary ID: XA1511US
• Status: Completed
• Start date: February 12, 2016
• Est. completion date: March 1, 2016

Study information

• Verified date: August 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12507
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of NVAF patients receiving 20 mg Rivaroxaban		At baseline
Primary	Number of NVAF patients receiving 15 mg Rivaroxaban		At baseline
Secondary	Baseline renal function		At baseline