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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

Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

Phase 3
Completed
Conditions
Deep Vein Thrombosis
Interventions
First Posted Date
2012-01-25
Last Posted Date
2017-01-18
Lead Sponsor
Bayer
Target Recruit Count
60
Registration Number
NCT01516840

Switching Study From Warfarin to Rivaroxaban

Phase 1
Completed
Conditions
Venous Thrombosis
Interventions
First Posted Date
2012-01-10
Last Posted Date
2015-02-09
Lead Sponsor
Bayer
Target Recruit Count
96
Registration Number
NCT01507051

Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Phase 3
Completed
Conditions
Superficial Vein Thrombosis
Interventions
First Posted Date
2011-12-26
Last Posted Date
2023-05-15
Lead Sponsor
GWT-TUD GmbH
Target Recruit Count
472
Registration Number
NCT01499953
Locations
🇩🇪

Universitätsklinikum Dresden, Dresden, Sachsen, Germany

🇩🇪

MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik, Berlin, Germany

🇩🇪

Franziskus-Krankenhaus Berlin, Berlin, Germany

and more 20 locations

Reversal of the Antithrombotic Action of New Oral Anticoagulants

Phase 4
Conditions
Thrombosis
Anticoagulant-induced Bleeding
Anticoagulant Overdosage
Hemorrhage
Interventions
First Posted Date
2011-11-23
Last Posted Date
2012-03-12
Lead Sponsor
Gines Escolar
Target Recruit Count
10
Registration Number
NCT01478282
Locations
🇪🇸

Hospital Clinic, Fundació Clinic (FCRB), Barcelona, Spain

Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Pharmacokinetics
Bioavailability
Interventions
First Posted Date
2011-11-03
Last Posted Date
2017-01-24
Lead Sponsor
Janssen Scientific Affairs, LLC
Target Recruit Count
55
Registration Number
NCT01464450

Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

Completed
Conditions
Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Interventions
First Posted Date
2011-10-03
Last Posted Date
2017-01-23
Lead Sponsor
Bayer
Target Recruit Count
2293
Registration Number
NCT01444586

Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention

Phase 2
Completed
Conditions
Cardiovascular Disease
Coronary Artery Disease
Interventions
First Posted Date
2011-09-29
Last Posted Date
2022-06-23
Lead Sponsor
Bayer
Target Recruit Count
108
Registration Number
NCT01442792

Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
First Posted Date
2011-09-19
Last Posted Date
2015-04-22
Lead Sponsor
Bayer
Target Recruit Count
28
Registration Number
NCT01436526

Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

Phase 3
Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2011-09-09
Last Posted Date
2018-06-07
Lead Sponsor
Martini Hospital Groningen
Target Recruit Count
148
Registration Number
NCT01431456
Locations
🇳🇱

Martini Ziekenhuis, Groningen, Netherlands

A Study to Explore the Pharmacodynamic Changes When Transitioning From Rivaroxaban to Warfarin in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-07-22
Last Posted Date
2017-01-24
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
46
Registration Number
NCT01400646
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