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
-

Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

First Posted Date
2018-07-30
Last Posted Date
2018-07-30
Lead Sponsor
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Target Recruit Count
100
Registration Number
NCT03605433
Locations
🇵🇹

Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

First Posted Date
2018-06-28
Last Posted Date
2023-04-06
Lead Sponsor
Pfizer
Target Recruit Count
64684
Registration Number
NCT03572972
Locations
🇰🇷

Korea University Hospital, Seoul, Korea, Republic of

Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)

First Posted Date
2018-04-06
Last Posted Date
2019-01-10
Lead Sponsor
Yonsei University
Target Recruit Count
150
Registration Number
NCT03490994
Locations
🇰🇷

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Republic of

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy

First Posted Date
2018-03-13
Last Posted Date
2021-07-30
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
1512
Registration Number
NCT03463317
Locations
🇩🇪

Vivantes Klinik Am Urban, Kardiologie, Berlin, Germany

🇩🇪

Charité Universitätsmedizin Berlin, CBF, Kardiologie, Berlin, Germany

🇩🇪

Vivantes Klinikum Neukölln, Kardiologie, Berlin, Germany

and more 23 locations

Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

First Posted Date
2018-02-22
Last Posted Date
2023-06-09
Lead Sponsor
Pfizer
Target Recruit Count
51690
Registration Number
NCT03441633
Locations
🇪🇸

IDIAP Jordi Gol, Barcelona, Cataluña, Spain

Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma

First Posted Date
2018-02-09
Last Posted Date
2024-02-29
Lead Sponsor
Lawson Health Research Institute
Target Recruit Count
57
Registration Number
NCT03428373
Locations
🇨🇦

London Health Sciences Centre, London, Ontario, Canada

Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

First Posted Date
2018-01-29
Last Posted Date
2021-02-04
Lead Sponsor
Pirogov Russian National Research Medical University
Target Recruit Count
90
Registration Number
NCT03413618
Locations
🇷🇺

Clinical Hospital no.1 of the President's Administration of Russian Federation, Moscow, Russian Federation

Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

First Posted Date
2018-01-19
Last Posted Date
2020-08-07
Lead Sponsor
Indiana University
Target Recruit Count
1300
Registration Number
NCT03404635
Locations
🇺🇸

Eskenazi Health System, Indianapolis, Indiana, United States

🇺🇸

Indiana University Health Methodist Hospital, Indianapolis, Indiana, United States

The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-11-06
Last Posted Date
2023-01-17
Lead Sponsor
Ottawa Heart Institute Research Corporation
Target Recruit Count
40
Registration Number
NCT03331484
Locations
🇨🇦

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects

First Posted Date
2017-10-16
Last Posted Date
2023-02-24
Lead Sponsor
Portola Pharmaceuticals
Target Recruit Count
108
Registration Number
NCT03310021
Locations
🇺🇸

WCCT Global, Cypress, California, United States

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