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
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
- Conditions
- Pulmonary Embolism
- Interventions
- First Posted Date
- 2007-02-26
- Last Posted Date
- 2014-02-27
- Lead Sponsor
- Bayer
- Target Recruit Count
- 4833
- Registration Number
- NCT00439777
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
- Conditions
- Venous Thromboembolism
- Interventions
- Drug: Placebo
- First Posted Date
- 2007-02-26
- Last Posted Date
- 2014-11-04
- Lead Sponsor
- Bayer
- Target Recruit Count
- 1197
- Registration Number
- NCT00439725
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
- Conditions
- Atrial FibrillationStrokeEmbolism
- Interventions
- Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)
- First Posted Date
- 2006-11-27
- Last Posted Date
- 2014-04-29
- Target Recruit Count
- 14269
- Registration Number
- NCT00403767
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
- Conditions
- Acute Coronary Syndrome
- Interventions
- First Posted Date
- 2006-11-22
- Last Posted Date
- 2012-10-04
- Target Recruit Count
- 3490
- Registration Number
- NCT00402597
An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study
- Conditions
- Venous Thromboembolism
- Interventions
- First Posted Date
- 2006-11-22
- Last Posted Date
- 2014-12-23
- Lead Sponsor
- Bayer
- Target Recruit Count
- 613
- Registration Number
- NCT00402467
Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
- Conditions
- Venous Thromboembolism
- Interventions
- First Posted Date
- 2006-11-14
- Last Posted Date
- 2009-05-08
- Lead Sponsor
- Bayer
- Target Recruit Count
- 726
- Registration Number
- NCT00398905
Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
- Conditions
- Venous Thromboembolism
- Interventions
- First Posted Date
- 2006-11-07
- Last Posted Date
- 2014-10-28
- Lead Sponsor
- Bayer
- Target Recruit Count
- 877
- Registration Number
- NCT00396786
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
- Conditions
- Venous Thromboembolism
- Interventions
- Drug: (LMW) Heparin + Vitamin K Antagonist
- First Posted Date
- 2006-11-03
- Last Posted Date
- 2014-10-28
- Lead Sponsor
- Bayer
- Target Recruit Count
- 543
- Registration Number
- NCT00395772
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.
- Conditions
- PreventionVenous Thromboembolism
- Interventions
- First Posted Date
- 2006-08-09
- Last Posted Date
- 2014-10-27
- Lead Sponsor
- Bayer
- Target Recruit Count
- 2531
- Registration Number
- NCT00361894
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
- Conditions
- Venous Thromboembolism
- Interventions
- First Posted Date
- 2006-08-09
- Last Posted Date
- 2014-11-04
- Lead Sponsor
- Bayer
- Target Recruit Count
- 3148
- Registration Number
- NCT00362232
Drug Development Updates
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