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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

BAY59-7939 Japanese in Atrial Fibrillation (2nd)

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
100
Registration Number
NCT00973323

ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Phase 2
Completed
Conditions
Prevention
Thromboembolism
Interventions
First Posted Date
2009-02-10
Last Posted Date
2014-12-17
Lead Sponsor
Bayer
Target Recruit Count
641
Registration Number
NCT00839826

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Phase 2
Completed
Conditions
Venous Thrombosis
Deep Vein Thrombosis
Interventions
Drug: Enoxaparin/Vitamin K-Antagonist
First Posted Date
2009-02-09
Last Posted Date
2023-09-07
Lead Sponsor
Bayer
Target Recruit Count
613
Registration Number
NCT00839163

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Completed
Conditions
Venous Thromboembolism
Interventions
Drug: Standard care treatment for VTE prophylaxis
First Posted Date
2009-01-29
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
19076
Registration Number
NCT00831714

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Phase 3
Completed
Conditions
Myocardial Infarction
Myocardial Ischemia
Acute Coronary Syndrome
Unstable Angina
Interventions
Drug: Placebo
Drug: Standard of care
First Posted Date
2008-12-17
Last Posted Date
2014-09-17
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
15526
Registration Number
NCT00809965

Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer

Phase 2
Completed
Conditions
Venous Thrombosis
Deep Vein Thrombosis
Interventions
First Posted Date
2008-11-06
Last Posted Date
2015-11-18
Lead Sponsor
Bayer
Target Recruit Count
25
Registration Number
NCT00786422

BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Phase 2
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2008-10-24
Last Posted Date
2014-12-25
Lead Sponsor
Bayer
Target Recruit Count
36
Registration Number
NCT00779064

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

First Posted Date
2007-12-12
Last Posted Date
2016-09-15
Lead Sponsor
Bayer
Target Recruit Count
8101
Registration Number
NCT00571649
Locations
🇦🇷

Sanatorio Mitre, Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

🇨🇦

CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada

🇨🇦

Hotel Dieu-Grace Hospital, Windsor, Ontario, Canada

and more 10 locations

Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

First Posted Date
2007-07-02
Last Posted Date
2015-04-20
Lead Sponsor
Bayer
Target Recruit Count
1280
Registration Number
NCT00494871

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

Phase 3
Completed
Conditions
Venous Thrombosis
Interventions
First Posted Date
2007-02-26
Last Posted Date
2014-02-27
Lead Sponsor
Bayer
Target Recruit Count
3449
Registration Number
NCT00440193
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