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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
Associated Therapies
-

Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..

Active, not recruiting
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2020-03-05
Last Posted Date
2023-06-06
Lead Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Target Recruit Count
700
Registration Number
NCT04297150
Locations
🇪🇸

Hospital Universitario de La Princesa, Madrid, Spain

🇪🇸

Hospital Gómez Ulla, Madrid, Spain

🇪🇸

Hospital Universitario de La Paz, Madrid, Spain

and more 3 locations

Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2020-02-17
Last Posted Date
2021-11-01
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Target Recruit Count
12
Registration Number
NCT04271293
Locations
🇮🇹

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

Phase 3
Conditions
Aortic Valve Stenosis
Interventions
First Posted Date
2019-11-21
Last Posted Date
2022-07-27
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
100
Registration Number
NCT04171726
Locations
🇳🇱

Erasmus MC, Rotterdam, Netherlands

Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Not Applicable
Completed
Conditions
Atrial Fibrillation
Anticoagulants and Bleeding Disorders
Interventions
First Posted Date
2019-10-10
Last Posted Date
2020-08-03
Lead Sponsor
Samsung Medical Center
Target Recruit Count
60
Registration Number
NCT04121767
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy

Phase 4
Completed
Conditions
Thromboembolism
Cancer
Interventions
First Posted Date
2019-08-28
Last Posted Date
2023-05-30
Lead Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Target Recruit Count
150
Registration Number
NCT04072068
Locations
🇮🇹

Azienda Ospedalier Spedali Civili di Brescia, Brescia, Italy

🇮🇹

Ospedale S.Giacomo, Castelfranco Veneto, Italy

🇮🇹

Ospedale di Faenza, Faenza, Italy

and more 15 locations

DOAC Versus VKA After Cardiac Surgery

Phase 2
Withdrawn
Conditions
Anticoagulant-induced Bleeding
Interventions
First Posted Date
2019-06-28
Last Posted Date
2023-03-13
Lead Sponsor
Laval University
Registration Number
NCT04002011

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

Phase 3
Recruiting
Conditions
Stroke, Ischemic
Interventions
First Posted Date
2019-05-23
Last Posted Date
2023-08-16
Lead Sponsor
University of Zurich
Target Recruit Count
620
Registration Number
NCT03961334
Locations
🇬🇷

Attikon University Hospital, Athens, Greece

🇪🇸

Hospital Universitario Virgen Macarena, Sevilla, Spain

🇨🇭

University Hospital of Basel, Basel, Switzerland

and more 11 locations

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

Phase 4
Recruiting
Conditions
Intracranial Hemorrhages
Atrial Fibrillation
Interventions
Other: Non-anticoagulant medical therapy
Drug: Edoxaban
First Posted Date
2019-05-15
Last Posted Date
2024-07-05
Lead Sponsor
Population Health Research Institute
Target Recruit Count
1200
Registration Number
NCT03950076
Locations
🇦🇷

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

🇦🇹

Medical University of Innsbruck, Innsbruck, Austria

🇧🇪

UZ Brussel, Brussel, Belgium

and more 149 locations

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Phase 4
Completed
Conditions
Atrial Fibrillation
Left Atrial Appendage Thrombosis
Interventions
First Posted Date
2019-02-15
Last Posted Date
2024-08-19
Lead Sponsor
Keimyung University Dongsan Medical Center
Target Recruit Count
36
Registration Number
NCT03840291
Locations
🇰🇷

Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of

🇰🇷

Catholic University of Korea, Incheon St. Mary's hospital, Incheon, Korea, Republic of

🇰🇷

Pusan National University Hospital, Pusan, Korea, Republic of

and more 9 locations

Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

Phase 2
Conditions
Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
Interventions
First Posted Date
2018-06-26
Last Posted Date
2018-06-26
Lead Sponsor
Samsung Medical Center
Target Recruit Count
40
Registration Number
NCT03570281
Locations
🇰🇷

Department of Neurology, Samsung Medical Center, Seoul, Korea, Republic of

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