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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
-

Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)

Phase 3
Completed
Conditions
MV(Mitral Valve) Repair
Interventions
Drug: Edoxaban
Drug: Warfarin
Drug: parenteral anti-coagulant (UFH)
First Posted Date
2017-08-09
Last Posted Date
2020-01-02
Lead Sponsor
Yonsei University
Target Recruit Count
220
Registration Number
NCT03244319
Locations
🇰🇷

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Republic of

Start or STop Anticoagulants Randomised Trial (SoSTART)

Phase 3
Completed
Conditions
Subdural Hematoma
Intraventricular Hemorrhage
Intracranial Hemorrhages
Intracranial Hemorrhage, Hypertensive
Subarachnoid Hemorrhage
Atrial Fibrillation
Microhaemorrhage
Atrial Flutter
Small Vessel Cerebrovascular Disease
Interventions
First Posted Date
2017-05-15
Last Posted Date
2022-04-08
Lead Sponsor
University of Edinburgh
Target Recruit Count
203
Registration Number
NCT03153150
Locations
🇬🇧

Frimley Park Hospital, Frimley, United Kingdom

🇬🇧

Gloucestershire Royal Hospital, Gloucester, United Kingdom

🇬🇧

Pinderfields Hospital, Wakefield, United Kingdom

and more 64 locations

A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

Phase 4
Conditions
Left Atrial Appendage Closure
Non-Valvular Atrial Fibrillation
Interventions
First Posted Date
2017-03-23
Last Posted Date
2017-07-11
Lead Sponsor
Scripps Health
Target Recruit Count
75
Registration Number
NCT03088072
Locations
🇺🇸

Scripps Health, La Jolla, California, United States

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Not Applicable
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2016-11-16
Last Posted Date
2019-02-12
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
607
Registration Number
NCT02964949
Locations
🇱🇹

Vilnius University Hospital Santariskiu Clinic Public Institution, Vilnius, Lithuania

🇵🇱

Synexus Polska Sp z o o Oddział we Wroclawiu, Wroclaw, Poland

🇷🇺

FSHI "MSU of MoIA of RF of Kemerovo Region", Kemerovo, Russian Federation

and more 227 locations

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2016-11-02
Last Posted Date
2019-12-23
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
352
Registration Number
NCT02952599
Locations
🇨🇳

Far Eastern Memorial Hospital, New Taipei City, Banciao District, Taiwan

🇨🇳

Taipei Veterans General Hospital, Taipei, Beitou District, Taiwan

🇨🇳

Chang Gung Memorial Hospital, KaoHsiung, Kaohsiung, Niaosong District, Taiwan

and more 16 locations

Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2016-11-01
Last Posted Date
2021-01-12
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
3008
Registration Number
NCT02951039
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei, Beitou District, Taiwan

🇰🇷

Soon Chun Hyang University Hospital Cheonan, Cheonan, Chungcheongnam-do, Korea, Republic of

🇰🇷

GangNeung Asan Hospital, Gangneung, Gangwon-do, Korea, Republic of

and more 44 locations

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Completed
Conditions
Venous Thromboembolism
Interventions
First Posted Date
2016-10-25
Last Posted Date
2022-05-02
Lead Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Target Recruit Count
2809
Registration Number
NCT02943993
Locations
🇩🇪

International Clinical Research GmbH, Germering, Germany

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2016-10-25
Last Posted Date
2022-06-01
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
13980
Registration Number
NCT02944019
Locations
🇦🇹

Wilhelminenspital der Stadt Wien,Kardiologie,Wien, Wien, Austria

🇧🇪

Clinique St-Jean, Cardiology, Bruxelles, Bruxelles, Belgium

🇦🇹

Universitaetsklinik Graz, Onkologie, Graz, Graz, Austria

and more 720 locations

Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
Drug: Edoxaban
Drug: VKA-Based Regimen
First Posted Date
2016-10-24
Last Posted Date
2019-09-23
Lead Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Target Recruit Count
632
Registration Number
NCT02942576
Locations
🇵🇱

Klinika Intensywnej Terapii Kardiologicznej, Łódź, Poland

🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

🇰🇷

Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of

and more 71 locations

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

Phase 4
Completed
Conditions
Diabetes
Interventions
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

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