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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

Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China

Completed
Conditions
Non-valvular Atrial Fibrillation
Interventions
First Posted Date
2021-02-10
Last Posted Date
2025-01-09
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
5000
Registration Number
NCT04747496
Locations
🇨🇳

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

🇨🇳

Changzhou No.2 People'S Hospital, Changzhou, Jiangsu, China

🇨🇳

Taiyuan Central Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

and more 93 locations

Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

First Posted Date
2021-01-29
Last Posted Date
2023-10-05
Lead Sponsor
Kyushu University
Target Recruit Count
74
Registration Number
NCT04730037
Locations
🇯🇵

Kyushu University Hospital, Fukuoka, Japan

Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: DA-5209 60mg Tab
First Posted Date
2020-12-17
Last Posted Date
2021-02-09
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
121
Registration Number
NCT04671316
Locations
🇰🇷

H Plus Yangji Hospital, Seoul, Korea, Republic of

NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

Completed
Conditions
Anticoagulant-induced Bleeding
Surgery, Oral
Hemorrhage
Oral Surgical Procedures
Postoperative Complications
Anticoagulants Causing Adverse Effects in Therapeutic Use
Interventions
First Posted Date
2020-12-10
Last Posted Date
2024-01-26
Lead Sponsor
Malmö University
Target Recruit Count
216
Registration Number
NCT04662515
Locations
🇸🇪

Skåne University Hospital, Helsingborg, Sweden

🇸🇪

Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University, Malmö, Sweden

Anticoagulation in Patients With Venous Thromboembolism and Cancer

Active, not recruiting
Conditions
Neoplasms
Embolism
Interventions
First Posted Date
2020-11-06
Last Posted Date
2025-05-06
Lead Sponsor
Pfizer
Target Recruit Count
1
Registration Number
NCT04618913
Locations
🇬🇧

Pfizer Investigational Site, London, United Kingdom

Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey

Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2020-10-20
Last Posted Date
2023-07-03
Lead Sponsor
Daiichi Sankyo Turkey, a Daiichi Sankyo Company
Target Recruit Count
1053
Registration Number
NCT04594915
Locations
🇹🇷

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH, Istanbul, Turkey

🇹🇷

Tekirdağ Şehir Hastanesi, Tekirdağ, Turkey

🇹🇷

Başkent University Alanya Practice and Research Hospital, Cardiology Clinic, Antalya, Alanya, Turkey

and more 42 locations

Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

Completed
Conditions
Non-valvular Atrial Fibrillation
Interventions
First Posted Date
2020-08-20
Last Posted Date
2023-08-02
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
666
Registration Number
NCT04519944
Locations
🇩🇪

Zentralklinik Bad Berka, Bad Berka, Germany

🇩🇪

Kerckhoff-Klinik GmbH, Bad Nauheim, Germany

🇩🇪

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald, Bad Friedrichshall, Germany

and more 63 locations

CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19

Phase 3
Terminated
Conditions
COVID-19
SARS-CoV Infection
Interventions
First Posted Date
2020-08-18
Last Posted Date
2022-09-08
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
60
Registration Number
NCT04516941
Locations
🇨🇭

Bern University Hospital, Bern, Switzerland

🇮🇹

ASST Rhodense, Garbagnate Milanese, Italy

🇧🇪

Jessa Ziekenhuis, Hasselt, Belgium

and more 2 locations

Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

First Posted Date
2020-07-20
Last Posted Date
2024-08-21
Lead Sponsor
Cardioangiologisches Centrum Bethanien
Target Recruit Count
84
Registration Number
NCT04477837
Locations
🇩🇪

Cardioangiology Center Bethanien (CCB), Frankfurt am Main, Germany

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
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