MedPath

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

A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)

Completed
Conditions
Treatment of Venous Thromboembolism in Cancer Patients
Interventions
Drug: Low molecular weight heparin (LMWH)
Drug: other NOACs
First Posted Date
2021-12-09
Last Posted Date
2023-12-18
Lead Sponsor
Bayer
Target Recruit Count
5737
Registration Number
NCT05150938
Locations
🇸🇪

Swedish registries, Multiple Locations, Many Locations, Sweden

Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects

Phase 1
Completed
Conditions
Coagulation Disorder
Interventions
First Posted Date
2021-12-09
Last Posted Date
2023-06-02
Lead Sponsor
VarmX B.V.
Target Recruit Count
105
Registration Number
NCT05152420
Locations
🇳🇱

QPS Netherlands B.V., Groningen, Netherlands

A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

Phase 1
Completed
Conditions
Embolism and Thrombosis
Interventions
First Posted Date
2021-11-22
Last Posted Date
2022-03-08
Lead Sponsor
Addpharma Inc.
Target Recruit Count
38
Registration Number
NCT05128591
Locations
🇰🇷

H+ Yangji Hospital, Seoul, Korea, Republic of

Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients

Phase 4
Recruiting
Conditions
Thrombosis
Myocardial Infarction
Interventions
First Posted Date
2021-11-11
Last Posted Date
2023-09-22
Lead Sponsor
Nova Scotia Health Authority
Target Recruit Count
30
Registration Number
NCT05116995
Locations
🇨🇦

Nova Scotia Health, Halifax, Nova Scotia, Canada

A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer and Thrombosis (OSCAR-UK)

Completed
Conditions
Treatment of Venous Thromboembolism in Cancer Patients
Interventions
Drug: other DOACs
Drug: LMWH
First Posted Date
2021-11-09
Last Posted Date
2023-04-03
Lead Sponsor
Bayer
Target Recruit Count
2601
Registration Number
NCT05112666
Locations
🇬🇧

Many locations, Multiple Locations, United Kingdom

Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical Care

Phase 2
Conditions
COVID-19
Interventions
First Posted Date
2021-10-22
Last Posted Date
2022-03-10
Lead Sponsor
Scotmann Pharmaceuticals
Target Recruit Count
40
Registration Number
NCT05088928
Locations
🇵🇰

Rawalpindi Medical University, Rawalpindi, Punjab, Pakistan

Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Completed
Conditions
Deep Vein Thrombosis, Pulmonary Embolus
Interventions
First Posted Date
2021-10-19
Last Posted Date
2023-07-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
89215
Registration Number
NCT05083455
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF

Phase 3
Completed
Conditions
Myocardial Infarction, Acute
Left Ventricular Thrombus
Interventions
First Posted Date
2021-10-14
Last Posted Date
2024-07-10
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
560
Registration Number
NCT05077683
Locations
🇫🇷

HEGP, Paris, France

Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Phase 3
Recruiting
Conditions
Stroke
Intracranial Arteriosclerosis
Interventions
First Posted Date
2021-09-17
Last Posted Date
2025-05-18
Lead Sponsor
University of Florida
Target Recruit Count
1683
Registration Number
NCT05047172
Locations
🇺🇸

University of Alabama Hospital, Birmingham, Alabama, United States

🇺🇸

University of South Alabama University Hospital, Mobile, Alabama, United States

🇺🇸

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

and more 122 locations

High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

Active, not recruiting
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2021-09-09
Last Posted Date
2025-04-16
Lead Sponsor
Pfizer
Target Recruit Count
1
Registration Number
NCT05038228
Locations
🇬🇧

Pfizer Investigator, London, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath