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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

Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke

Phase 2
Not yet recruiting
Conditions
Elderly
Atrial Fibrillation (AF)
Ischemic Stroke
Interventions
First Posted Date
2025-03-28
Last Posted Date
2025-04-02
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
300
Registration Number
NCT06900725
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia

Phase 4
Not yet recruiting
Conditions
Staphylococcus Aureus Endocarditis
Staphylococcus Aureus Septicemia
Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bloodstream Infection
S. Aureus Bacteremia
S. Aureus Bloodstream Infection
Interventions
First Posted Date
2024-10-21
Last Posted Date
2024-10-21
Lead Sponsor
Emily McDonald
Target Recruit Count
300
Registration Number
NCT06650501
Locations
🇨🇦

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital), Montreal, Quebec, Canada

The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)

Not Applicable
Active, not recruiting
Conditions
Heart Diseases
Cardiovascular Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Valve Disease, Aortic
Interventions
First Posted Date
2024-06-10
Last Posted Date
2025-04-06
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
352
Registration Number
NCT06449469
Locations
🇩🇰

Aarhus University Hospital, Skejby, Aarhus, Denmark

🇩🇰

Rigshospitalet, Copenhagen, Denmark

Single Dose Trial of VMX-C001 in Healthy Subjects with and Without FXa Direct Oral Anticoagulant

Phase 1
Active, not recruiting
Conditions
Coagulation Disorder
Interventions
First Posted Date
2024-04-18
Last Posted Date
2024-11-18
Lead Sponsor
VarmX B.V.
Target Recruit Count
40
Registration Number
NCT06372483
Locations
🇳🇱

ICON, Groningen, Netherlands

Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery

Phase 1
Withdrawn
Conditions
Bariatric Surgery Candidate
Interventions
First Posted Date
2024-03-22
Last Posted Date
2024-03-22
Lead Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Registration Number
NCT06326138

EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation

Not Applicable
Recruiting
Conditions
Atrial Fibrillation
Fragility
Interventions
First Posted Date
2024-02-29
Last Posted Date
2024-02-29
Lead Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Target Recruit Count
168
Registration Number
NCT06285942
Locations
🇮🇹

Ospedale Policlinico San Martino, Genova, Italy

🇮🇹

AOU Maggiore della Carità, Novara, Italy

🇮🇹

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy

Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

Phase 3
Not yet recruiting
Conditions
Cancer
Thrombosis, Venous
Catheter Complications
Interventions
First Posted Date
2023-11-29
Last Posted Date
2023-11-29
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Target Recruit Count
366
Registration Number
NCT06149533
Locations
🇨🇳

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

DOAC in Patients with Child a or B Liver Cirrhosis

Phase 2
Recruiting
Conditions
Liver Cirrhosis
Interventions
First Posted Date
2023-05-22
Last Posted Date
2025-02-13
Lead Sponsor
Centre Hospitalier Universitaire Vaudois
Target Recruit Count
40
Registration Number
NCT05869591
Locations
🇨🇭

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Vaud, Switzerland

A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation

Recruiting
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2023-04-07
Last Posted Date
2024-07-29
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
1100
Registration Number
NCT05804747
Locations
🇰🇷

Korea University Ansan Hospital, Ansan, Korea, Republic of

🇰🇷

Dong-A University Hospital, Busan, Korea, Republic of

🇰🇷

Pusan National University Hospital, Busan, Korea, Republic of

and more 30 locations

Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Completed
Conditions
Auricular Fibrillation
Interventions
First Posted Date
2023-02-17
Last Posted Date
2025-04-11
Lead Sponsor
Galaxia Empírica
Target Recruit Count
411
Registration Number
NCT05732506
Locations
🇪🇸

Hospital San Pedro, Logroño, La Rioja, Spain

🇪🇸

Hospital Universitario Doctor José Molina Orosa, Arrecife, Las Palmas, Spain

🇪🇸

Hospital del Bierzo, Ponferrada, León, Spain

and more 32 locations
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