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Edoxaban

Generic Name
Edoxaban
Brand Names
Lixiana, Savaysa, Roteas
Drug Type
Small Molecule
Chemical Formula
C24H30ClN7O4S
CAS Number
480449-70-5
Unique Ingredient Identifier
NDU3J18APO
Background

Edoxaban is a member of the Novel Oral Anti-Coagulants (NOACs) class of drugs, and is a rapidly acting, oral, selective factor Xa inhibitor. By inhibiting factor Xa, a key protein in the coagulation cascade, edoxaban prevents the stepwise amplification of protein factors needed to form blood clots. It is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant. Traditionally, warfarin, a vitamin K antagonist, was used for stroke prevention in these individuals but effective use of this drug is limited by it's delayed onset, narrow therapeutic window, need for regular monitoring and INR testing, and numerous drug-drug and drug-food interactions. This has prompted enthusiasm for newer agents such as dabigatran, apixaban, and rivaroxaban for effective clot prevention. In addition to once daily dosing, the benefits over warfarin also include significant reductions in hemorrhagic stroke and GI bleeding, and improved compliance, which is beneficial as many patients will be on lifelong therapy.

Indication

Edoxaban is indicated for reducing the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). However, it should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.

Associated Conditions
Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Systemic Embolism

PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

First Posted Date
2023-02-10
Last Posted Date
2023-12-11
Lead Sponsor
HK inno.N Corporation
Target Recruit Count
87
Registration Number
NCT05723510
Locations
🇰🇷

Jeonbuk National University Hospital, Jeonju, Korea, Republic of

Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

Phase 2
Recruiting
Conditions
Mitral Valve Stenosis
Atrial Fibrillation
Stroke
Systemic Embolism
Interventions
First Posted Date
2022-09-14
Last Posted Date
2022-09-14
Lead Sponsor
Sung-Hwan Kim
Target Recruit Count
240
Registration Number
NCT05540587
Locations
🇰🇷

Bucheon St. Mary's hospital, Bucheon, Korea, Republic of

🇰🇷

Yeouido St. Mary's hospital, Yeongdeungpo-gu, Seoul, Korea, Republic of

🇰🇷

Seoul St. Mary's Hospital, Seoul, Seocho-gu, Korea, Republic of

and more 4 locations

Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

First Posted Date
2022-08-08
Last Posted Date
2022-08-08
Lead Sponsor
Doasense GmbH
Target Recruit Count
24
Registration Number
NCT05491460
Locations
🇩🇪

Clincial Research Serivces, Mannheim, Germany

Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation

Phase 4
Recruiting
Conditions
Non-Valvular Atrial Fibrillation
Interventions
First Posted Date
2022-04-11
Last Posted Date
2024-03-15
Lead Sponsor
China National Center for Cardiovascular Diseases
Target Recruit Count
120
Registration Number
NCT05320627
Locations
🇨🇳

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice For Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2022-03-02
Last Posted Date
2022-07-19
Lead Sponsor
Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company
Target Recruit Count
234
Registration Number
NCT05262322
Locations
🇬🇧

Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom

🇬🇧

Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde, Glasgow, United Kingdom

🇬🇧

Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust, Gloucester, United Kingdom

and more 5 locations

Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects

Phase 1
Completed
Conditions
Coagulation Disorder
Interventions
First Posted Date
2021-12-09
Last Posted Date
2023-06-02
Lead Sponsor
VarmX B.V.
Target Recruit Count
105
Registration Number
NCT05152420
Locations
🇳🇱

QPS Netherlands B.V., Groningen, Netherlands

Effects of Edoxaban on Platelet Aggregation

Phase 2
Completed
Conditions
SCAD
AMI
Interventions
First Posted Date
2021-11-16
Last Posted Date
2025-04-27
Lead Sponsor
University of Sao Paulo
Target Recruit Count
61
Registration Number
NCT05122455
Locations
🇧🇷

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Phase 3
Recruiting
Conditions
Aortic Stenosis
Interventions
First Posted Date
2021-09-05
Last Posted Date
2022-11-14
Lead Sponsor
Oslo University Hospital
Target Recruit Count
360
Registration Number
NCT05035277
Locations
🇳🇴

Haukeland University Hospital, Bergen, Norway

🇳🇴

Oslo Univesity Hospital - Ullevål, Oslo, Norway

🇳🇴

Oslo University Hospital - Rikshospitalet, Oslo, Norway

Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea

Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2021-08-26
Last Posted Date
2023-08-03
Lead Sponsor
Pfizer
Target Recruit Count
55759
Registration Number
NCT05022563
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam-si, Korea, Republic of

🇰🇷

Sungkyunkwan University, Suwon-si, Korea, Republic of

Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty

Conditions
Frailty
Stroke
Atrial Fibrillation
Anticoagulant-induced Bleeding
Interventions
First Posted Date
2021-05-07
Last Posted Date
2021-05-07
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
1000000
Registration Number
NCT04878497
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

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