Rivaroxaban

Generic Name: Rivaroxaban

Brand Names: Xarelto, Rivaroxaban Accord, Rivaroxaban Viatris (previously Rivaroxaban Mylan)

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₈ClN_₃O_₅S

CAS Number: 366789-02-8

Unique Ingredient Identifier: 9NDF7JZ4M3

Background: Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Indication: Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min).

Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients ≥2 years old with congenital heart disease following the Fontan procedure.

Associated Conditions: Cardiovascular Mortality, Deep Vein Thrombosis, Deep vein thrombosis recurrent, Major Adverse Cardiovascular Events, Myocardial Infarction, Pulmonary Embolism, Recurrent Pulmonary Embolism (Disorder), Recurrent Venous Thromboembolism, Stroke, Systemic Embolism, Thrombosis, Venous Thromboembolism

Clinical Trials

Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

Phase 3

Completed

Conditions: Hematoma

Interventions: Drug: Dabigatran
Drug: Rivaroxaban
Drug: Apixaban

First Posted Date: 2012-08-29

Last Posted Date: 2019-10-07

Lead Sponsor: Ottawa Heart Institute Research Corporation

Target Recruit Count: 663

Registration Number: NCT01675076

Locations: 🇨🇦
Victoria Cardiac Arrhythmia Trials Inc., Victoria, British Columbia, Canada
🇨🇦
University of Alberta-ECAT Group, Edmonton, Alberta, Canada
🇨🇦
Hamilton Health Sciences General Campus, Hamilton, Ontario, Canada

and more 12 locations

Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

Phase 3

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Vitamin K antagonist (VKA)

First Posted Date: 2012-08-29

Last Posted Date: 2015-04-30

Lead Sponsor: Bayer

Target Recruit Count: 1504

Registration Number: NCT01674647

A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Rivaroxaban 20 mg twice daily
Drug: Rivaroxaban 20 mg once daily
Drug: Beriplex P/N
Other: Saline
Drug: Profilnine SD

First Posted Date: 2012-08-03

Last Posted Date: 2017-01-24

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 35

Registration Number: NCT01656330

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

Phase 2

Completed

Conditions: Venous Thromboembolism
Haemorrhage

Interventions: Drug: placebo
Drug: Rivaroxaban

First Posted Date: 2012-06-27

Last Posted Date: 2021-05-21

Lead Sponsor: University of Padova

Target Recruit Count: 500

Registration Number: NCT01629381

Locations: 🇮🇹
Department of Internal Medicine, Hospital of Piacenza, Piacenza, Italy
🇮🇹
Thrombosis Center & Knee Arthroscopy and Sports Medicine Center, Humanitas Clinical Insitute, Rozzano, Milano, Italy
🇮🇹
Department of Orthopaedics and Traumatology, University Hospital "Galliera" of Genova, Genova, Italy

and more 6 locations