MedPath

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
-

Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

First Posted Date
2016-08-15
Last Posted Date
2020-05-06
Lead Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Target Recruit Count
1506
Registration Number
NCT02866175
Locations
🇺🇦

Kharkiv City Clinical Hospital #8, Kharkiv, Ukraine

🇬🇧

Altnagelvin Area Hospital, Londonderry, United Kingdom

🇬🇧

Golden Jubilee Hospital, Clydebank, United Kingdom

and more 197 locations

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Phase 3
Completed
Conditions
Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism
Interventions
Drug: Standard of Care
Drug: Edoxaban
First Posted Date
2016-06-14
Last Posted Date
2023-03-06
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
290
Registration Number
NCT02798471
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

East Carolina University, Greenville, North Carolina, United States

🇭🇷

Clinical Hospital Centre Rijeka, Rijeka, Croatia

and more 137 locations

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

Not Applicable
Completed
Conditions
Cancer
Venous Thromboembolism
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Blood Clot
Interventions
First Posted Date
2016-04-20
Last Posted Date
2023-10-03
Lead Sponsor
Alliance Foundation Trials, LLC.
Target Recruit Count
811
Registration Number
NCT02744092
Locations
🇺🇸

Washington Hospital, Fremont, California, United States

🇺🇸

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States

🇺🇸

Saint Joseph's Medical Center, Stockton, California, United States

and more 145 locations

Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

Phase 3
Terminated
Conditions
Atrial High Rate Episodes
Interventions
First Posted Date
2015-12-01
Last Posted Date
2023-07-28
Lead Sponsor
Atrial Fibrillation Network
Target Recruit Count
2608
Registration Number
NCT02618577
Locations
🇩🇪

Several Sites, Multiple Locations, Germany

🇬🇧

Several, Multiple Locations, United Kingdom

EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Phase 4
Terminated
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2015-09-28
Last Posted Date
2020-06-30
Lead Sponsor
Electrophysiology Research Foundation
Target Recruit Count
5
Registration Number
NCT02561897
Locations
🇺🇸

Electrophysiology Research Foundation, Warren, New Jersey, United States

Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography

Conditions
Heart Failure
First Posted Date
2015-05-20
Last Posted Date
2015-05-20
Lead Sponsor
LifeBridge Health
Target Recruit Count
40
Registration Number
NCT02448901
Locations
🇺🇸

Sinai Center for Thrombosis Research, Baltimore, Maryland, United States

Edoxaban for TIA and Acute Minor Stroke

Phase 2
Conditions
Stroke
Cerebral Infarction
Ischemia
Interventions
First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Xijing Hospital
Target Recruit Count
3700
Registration Number
NCT02221102
Locations
🇨🇳

Xijing Hospital, Xi'an, Shaanxi, China

Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban

Phase 2
Completed
Conditions
Anticoagulation Reversal
Interventions
Drug: PER977
Drug: Placebo
Drug: Edoxaban
First Posted Date
2014-08-04
Last Posted Date
2020-05-21
Lead Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Target Recruit Count
65
Registration Number
NCT02207257
Locations
🇺🇸

Quintiles, Overland Park, Kansas, United States

Cancer Venous Thromboembolism (VTE)

Phase 3
Completed
Conditions
Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
Interventions
Drug: Edoxaban
Drug: Dalteparin
Drug: Low molecular weight heparin
First Posted Date
2014-02-27
Last Posted Date
2019-03-06
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
1046
Registration Number
NCT02073682

Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2014-02-26
Last Posted Date
2019-03-15
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
2199
Registration Number
NCT02072434
Locations
🇪🇸

First site in, Madrid, Spain

🇪🇸

Third site in, Madrid, Spain

🇩🇪

Bad Friedrichshall, Heilbronn, Germany

and more 1 locations
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