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

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Phase 3

Recruiting

Conditions: Aortic Stenosis

Interventions: Drug: Acetylsalicylic acid
Drug: Apixaban
Drug: Rivaroxaban
Drug: Edoxaban

First Posted Date: 2021-09-05

Last Posted Date: 2022-11-14

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 360

Registration Number: NCT05035277

Locations: 🇳🇴
Haukeland University Hospital, Bergen, Norway
🇳🇴
Oslo Univesity Hospital - Ullevål, Oslo, Norway
🇳🇴
Oslo University Hospital - Rikshospitalet, Oslo, Norway

THromboprophylaxis in Sickle Cell Disease with Central Venous Catheters (THIS)

Phase 3

Terminated

Conditions: Sickle Cell Disease
Central Venous Catheter Thrombosis
Venous Thromboembolism

Interventions: Drug: Placebo
Drug: Rivaroxaban 10 MG

First Posted Date: 2021-09-02

Last Posted Date: 2025-03-19

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 4

Registration Number: NCT05033314

Locations: 🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦
London Health Sciences Center, London, Ontario, Canada
🇨🇦
Toronto General Hospital, Toronto, Ontario, Canada

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Phase 3

Recruiting

Conditions: Cancer
Venous Thromboembolism

Interventions: Drug: Rivaroxaban 10 MG

First Posted Date: 2021-08-31

Last Posted Date: 2023-09-29

Lead Sponsor: Ottawa Hospital Research Institute

Target Recruit Count: 1828

Registration Number: NCT05029063

Locations: 🇨🇦
HHS - Juravinski Hospital, Hamilton, Ontario, Canada
🇨🇦
Sault Area Hospital, Sault Ste Marie, Ontario, Canada
🇨🇦
Ottawa Hospital Research Institute- The Ottawa Hospital, Ottawa, Ontario, Canada

and more 4 locations

Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea

Completed

Conditions: Venous Thromboembolism

Interventions: Drug: Parenteral anticoagulant
Drug: Warfarin
Drug: Apixaban
Drug: Rivaroxaban
Drug: Dabigatran
Drug: Edoxaban

First Posted Date: 2021-08-26

Last Posted Date: 2023-08-03

Lead Sponsor: Pfizer

Target Recruit Count: 55759

Registration Number: NCT05022563

Locations: 🇰🇷
Seoul National University Bundang Hospital, Seongnam-si, Korea, Republic of
🇰🇷
Sungkyunkwan University, Suwon-si, Korea, Republic of