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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

A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)

Phase 1
Completed
Conditions
Thrombosis
Interventions
First Posted Date
2011-06-23
Last Posted Date
2015-10-02
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
42
Registration Number
NCT01379300

Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

Phase 2
Completed
Conditions
Prophylaxis of Venous Thromboembolic Events
Interventions
First Posted Date
2011-04-29
Last Posted Date
2012-08-23
Lead Sponsor
ThromboGenics
Target Recruit Count
632
Registration Number
NCT01344954
Locations
🇦🇹

KRANKENHAUS DES BARMHER.SCHW.Linz, Linz, Austria

🇷🇺

Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia, Saint-Petersburg, Russian Federation

🇧🇪

ZNA Antwerpen Locatie Middelheim, Antwerpen, Belgium

and more 33 locations

Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics

Phase 4
Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2010-09-28
Last Posted Date
2011-07-01
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
10
Registration Number
NCT01210755
Locations
🇫🇷

Clinical Research Centre, University Hospital Grenoble, Grenoble, France

Dose-confirmatory Bridging Study in Total Knee Replacement

Phase 3
Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2010-09-22
Last Posted Date
2017-01-18
Lead Sponsor
Bayer
Target Recruit Count
302
Registration Number
NCT01206972

Dose-confirmatory Bridging Study in Total Hip Replacement

Phase 3
Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2010-09-21
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
402
Registration Number
NCT01205932

Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

Phase 1
Completed
Conditions
Pediatrics
Venous Thrombosis
Interventions
First Posted Date
2010-06-17
Last Posted Date
2015-08-06
Lead Sponsor
Bayer
Target Recruit Count
59
Registration Number
NCT01145859

Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement

Phase 3
Completed
Conditions
Arthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Thromboembolism
Interventions
First Posted Date
2010-03-29
Last Posted Date
2017-03-17
Lead Sponsor
Ortho-McNeil Janssen Scientific Affairs, LLC
Target Recruit Count
56
Registration Number
NCT01094886

Xarelto Regulatory Post-Marketing Surveillance

Completed
Conditions
Venous Thromboembolism
Interventions
Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
First Posted Date
2009-12-10
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
3388
Registration Number
NCT01029743

BAY59-7939 in Atrial Fibrillation Once Daily (OD)

Phase 2
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2009-09-09
Last Posted Date
2014-12-30
Lead Sponsor
Bayer
Target Recruit Count
102
Registration Number
NCT00973245
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