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
Associated Therapies
-

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

First Posted Date
2017-02-16
Last Posted Date
2022-03-11
Lead Sponsor
Fadoi Foundation, Italy
Target Recruit Count
582
Registration Number
NCT03055026
Locations
🇮🇹

Ospedale San Donato, Arezzo, Italy

🇮🇹

AOU Careggi, Firenze, Italy

🇮🇹

Ospedale San Matteo degli Infermi, Spoleto, Perugia, Italy

and more 14 locations

Anticoagulation for Advanced Cirrhotic Patients After TIPS

Not Applicable
Recruiting
Conditions
Interventions
First Posted Date
2016-12-29
Last Posted Date
2022-10-25
Lead Sponsor
Air Force Military Medical University, China
Target Recruit Count
254
Registration Number
NCT03005444
Locations
🇨🇳

Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China

🇨🇳

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

🇨🇳

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

and more 8 locations

ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)

First Posted Date
2016-10-18
Last Posted Date
2020-11-10
Lead Sponsor
University of Pavia
Target Recruit Count
300
Registration Number
NCT02935855
Locations
🇮🇹

IRCCS Policlinico San Matteo, Pavia, Italy

Rivaroxaban for Patients With Antiphospholipid Syndrome

First Posted Date
2016-10-06
Last Posted Date
2018-05-11
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Target Recruit Count
190
Registration Number
NCT02926170
Locations
🇪🇸

Vall d'Hebron University Hospital, Barcelona, Spain

Rivaroxaban in Mechanical Valves: RMV Study

First Posted Date
2016-09-09
Last Posted Date
2018-03-13
Lead Sponsor
Hospital Ana Nery
Registration Number
NCT02894307

Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

First Posted Date
2016-07-14
Last Posted Date
2020-01-18
Lead Sponsor
ECRI bv
Target Recruit Count
231
Registration Number
NCT02833948
Locations
🇳🇱

Erasmus M.C, Rotterdam, Netherlands

🇸🇪

Skåne University Hospital, Lund, Sweden

🇸🇪

Karolinska University Hospital, Stockholm, Sweden

and more 22 locations

RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

First Posted Date
2016-07-12
Last Posted Date
2023-11-13
Lead Sponsor
Indiana University
Target Recruit Count
19
Registration Number
NCT02829957
Locations
🇺🇸

Eskenazi Health System, Indianapolis, Indiana, United States

🇺🇸

Indiana University Health Methodist Hospital, Indianapolis, Indiana, United States

Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

First Posted Date
2016-06-23
Last Posted Date
2024-12-11
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
20000
Registration Number
NCT02810704
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

🇺🇸

UCLA, Los Angeles, California, United States

and more 28 locations
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