Rivaroxaban

Generic Name
Rivaroxaban
Brand Names
Xarelto, Rivaroxaban Accord, Rivaroxaban Viatris (previously Rivaroxaban Mylan)
Drug Type
Small Molecule
Chemical Formula
C19H18ClN3O5S
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
Associated Therapies
-

Multicenter Prospective Randomized Trial of the Effect of Rivaroxaban on Survival and Development of Complications of Portal Hypertension in Patients With Cirrhosis

Phase 3
Conditions
Interventions
First Posted Date
2015-12-31
Last Posted Date
2018-04-25
Lead Sponsor
David Garcia Cinca
Target Recruit Count
160
Registration Number
NCT02643212
Locations
🇪🇸

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

🇪🇸

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, Spain

🇪🇸

Hospital German Trias i Pujol, Badalona, Barcelona, Spain

and more 11 locations

Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study

First Posted Date
2015-12-30
Last Posted Date
2015-12-30
Lead Sponsor
Japan Cardiovascular Research Foundation
Target Recruit Count
2200
Registration Number
NCT02642419
Locations
🇯🇵

Japan Cardiovascular Research Foundation, Suita, Osaka, Japan

Treatment of Splanchnic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study

First Posted Date
2015-12-10
Last Posted Date
2018-11-27
Lead Sponsor
Università degli Studi dell'Insubria
Target Recruit Count
100
Registration Number
NCT02627053
Locations
🇨🇦

University of Western Ontario, London, Canada

🇨🇦

University of Ottawa, Ottawa, Canada

🇮🇹

Ospedale di Circolo, Varese, Italy

and more 1 locations

Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients

First Posted Date
2015-11-20
Last Posted Date
2019-01-28
Lead Sponsor
Onze Lieve Vrouw Hospital
Target Recruit Count
117
Registration Number
NCT02610933
Locations
🇧🇪

OLV Hospital, Aalst, Belgium

Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients

First Posted Date
2015-10-22
Last Posted Date
2021-05-03
Lead Sponsor
AIO-Studien-gGmbH
Target Recruit Count
246
Registration Number
NCT02583191
Locations
🇩🇪

Uniklinik, Aachen, Germany

A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-10-22
Last Posted Date
2018-06-01
Lead Sponsor
Janssen Scientific Affairs, LLC
Target Recruit Count
114
Registration Number
NCT02584660

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-09-24
Last Posted Date
2024-10-15
Lead Sponsor
Ottawa Hospital Research Institute
Target Recruit Count
72
Registration Number
NCT02559856
Locations
🇨🇦

Hamilton General Hospital, Hamilton, Ontario, Canada

🇨🇦

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

🇨🇦

University of Alberta, Edmonton, Alberta, Canada

and more 1 locations

A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-09-22
Last Posted Date
2019-09-12
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
841
Registration Number
NCT02555878
© Copyright 2024. All Rights Reserved by MedPath