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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

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

Completed
Conditions
Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Acute Coronary Syndrome
Interventions
First Posted Date
2013-09-23
Last Posted Date
2021-10-22
Lead Sponsor
Bayer
Target Recruit Count
665533
Registration Number
NCT01947959

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (UK)

Completed
Conditions
Pulmonary Embolism
Venous Thrombosis
Atrial Fibrillation
Acute Coronary Syndrome
Interventions
First Posted Date
2013-09-23
Last Posted Date
2021-09-23
Lead Sponsor
Bayer
Target Recruit Count
50299
Registration Number
NCT01947998

Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

Phase 2
Conditions
Ischemic Stroke
TIA
Interventions
First Posted Date
2013-08-16
Last Posted Date
2013-08-16
Lead Sponsor
Xijing Hospital
Target Recruit Count
3700
Registration Number
NCT01923818
Locations
🇨🇳

Xijing Hospital, Xi'an, Shaanxi, China

A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure

Phase 3
Completed
Conditions
Coronary Artery Disease
Heart Failure
Interventions
Drug: Placebo
Other: Standard of care for heart failure and coronary artery disease
First Posted Date
2013-06-14
Last Posted Date
2019-05-10
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
5081
Registration Number
NCT01877915

Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2013-05-16
Last Posted Date
2017-01-18
Lead Sponsor
Bayer
Target Recruit Count
106
Registration Number
NCT01855139

Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)

Completed
Conditions
Venous Thrombosis
Interventions
First Posted Date
2013-05-16
Last Posted Date
2017-01-18
Lead Sponsor
Bayer
Target Recruit Count
131
Registration Number
NCT01855100

Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

Phase 1
Completed
Conditions
Biological Availability
Interventions
First Posted Date
2013-05-15
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
14
Registration Number
NCT01853800

Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2013-04-24
Last Posted Date
2016-07-25
Lead Sponsor
Bayer
Target Recruit Count
60
Registration Number
NCT01839357

Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication

Completed
Conditions
Venous Thrombosis
Interventions
First Posted Date
2013-03-06
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
113
Registration Number
NCT01805544
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