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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

The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics

Recruiting
Conditions
Pulmonary Embolism
Interventions
First Posted Date
2024-04-12
Last Posted Date
2024-04-12
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
300
Registration Number
NCT06362343
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

Rivaroxaban Sotorasib Interaction Study

Phase 4
Completed
Conditions
Drug Drug Interaction Study
Interventions
First Posted Date
2024-03-18
Last Posted Date
2024-04-30
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
21
Registration Number
NCT06314763
Locations
🇳🇱

Radboud university medical centre, Nijmegen, Netherlands

An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism

Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2024-02-26
Last Posted Date
2024-12-05
Lead Sponsor
Bayer
Target Recruit Count
320
Registration Number
NCT06278051
Locations
🇯🇵

Many facilities, Multiple Locations, Japan

🇯🇵

Bayer, Osaka, Japan

Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation

Not Applicable
Recruiting
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2024-01-22
Last Posted Date
2024-05-29
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
400
Registration Number
NCT06216769
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients

Not Applicable
Recruiting
Conditions
Glioma, Malignant
Interventions
First Posted Date
2024-01-09
Last Posted Date
2024-01-09
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
320
Registration Number
NCT06196918
Locations
🇨🇳

The First People's Hospital of Foshan, Foshan, Guangdong, China

🇨🇳

Beijing Tiantan Hospital, Beijing, Beijing, China

🇨🇳

Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China

and more 5 locations

RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

Phase 3
Recruiting
Conditions
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Lower Limb Trauma
Thromboprophylaxis
Immobilisation
Interventions
Drug: Low Heparin Molecular Weight
First Posted Date
2024-01-08
Last Posted Date
2025-04-02
Lead Sponsor
University Hospital, Angers
Target Recruit Count
1424
Registration Number
NCT06195540
Locations
🇫🇷

Lariboisière hospital, emergency department, Paris, France

🇫🇷

Saint-Antoine Hospital, Emergency department, Paris, France

🇫🇷

Rennes University Hospital, Emergency department, Rennes, France

and more 30 locations

An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

Recruiting
Conditions
Congenital Heart Disease
Fontan Procedure
Children
Prevention of Venous Thromboembolism
Interventions
First Posted Date
2024-01-05
Last Posted Date
2025-04-24
Lead Sponsor
Bayer
Target Recruit Count
50
Registration Number
NCT06193863
Locations
🇯🇵

Many Locations, Multiple Locations, Japan

Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation

Phase 4
Recruiting
Conditions
Atrial Fibrillation
Anticoagulant Adverse Reaction
Interventions
First Posted Date
2024-01-02
Last Posted Date
2024-01-05
Lead Sponsor
Korea University Anam Hospital
Target Recruit Count
940
Registration Number
NCT06187311
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation

Phase 4
Not yet recruiting
Conditions
Atrial Fibrillation
Anticoagulant Adverse Reaction
Major Adverse Cardiac Events
Stroke
Interventions
First Posted Date
2023-10-31
Last Posted Date
2024-07-18
Lead Sponsor
China National Center for Cardiovascular Diseases
Target Recruit Count
4374
Registration Number
NCT06108414
Locations
🇨🇳

National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention

Phase 4
Not yet recruiting
Conditions
Atrial Fibrillation
Coronary Artery Disease
Interventions
First Posted Date
2023-10-26
Last Posted Date
2023-10-26
Lead Sponsor
J.P.S Henriques
Target Recruit Count
50
Registration Number
NCT06103266
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