Real-world Dosing Patterns of Rivaroxaban in the United States

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT03242278
• Lead Sponsor: Bayer

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.

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-02-12
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Study First Submitted: 2017-07-26
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12507

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NVAF patients receiving 20 mg rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)
NVAF patients receiving 15 mg rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)

Primary Outcome Measures

Name	Time	Method
Number of NVAF patients receiving 20 mg Rivaroxaban	At baseline
Number of NVAF patients receiving 15 mg Rivaroxaban	At baseline

Secondary Outcome Measures

Name	Time	Method
Baseline renal function	At baseline