EDOSURE – Edoxaban Clinical Research Program

EdoSure

The goal of EDOSURE is to generate new clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.

More than 100,000 patients worldwide are expected to participate in the edoxaban clinical research program, EDOSURE, which is comprised of more than 10 RCTs (randomized, controlled trials), non-interventional studies and registries including completed, ongoing and future research.

The RCTs include:

- ENGAGE AF -TIMI 48(Effective a NticoaGulation with factor XA next GEneration in Atrial Fibrillation), in NVAF patients at moderate-to-high risk of thromboembolic events

- Hokusai-VTE(Edoxaban in Venous Thromboembolism), in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both

- ENSURE-AF(EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion

- ENTRUST-AF PCI(EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention

- Hokusai-VTE CANCER(Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event

- ELDERCARE-AF(Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan

- ELIMINATE-AF(EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation)

- ENVISAGE-TAVI AF(EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) – Atrial Fibrillation)

Randomized-controlled Clinical trials in AF and VTE

Clinical Setting First Data Disclosure
Non valvular atrial fibrillation patients

Presented at AHA 2013

NCT00781391

VTE patients

Presented at ESC 2013

NCT00986154

AF patients undergoing electrical cardioversion

Presented at ESC 2016

NCT02072434

AF patients undergoing catheter ablation

Presented at EHRA 2019

NCT02942576

AF patients undergoing PCI

(Still ongoing)

NCT02866175

AF patients undergoing transcatheter aortic valve implantation

(Still ongoing)

NCT02943785

80 years or older Japanese AF patients who are ineligible for current OAC therapy

(Still ongoing)

NCT02801669

Patients with VTE associated with cancer

Presented at ASH 2017

NCT02073682

In addition, EDOSURE’s global and regional non-interventional studies and registries provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:

- ETNA-AF(Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation)

- ETNA-VTE(Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)

- EMIT-AF/VTE(Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE)

- Prolongation PREFER in AF(PREvention oF thromboembolic events – European Registry) in patients with AF

- ANAFIE(All Nippon AF In Elderly) Registry in Japan

- Cancer-VTE Registry in Japan

Non-interventional studies and registries

Non-interventional study Registry
Edoxaban Treatment in routiNe clinical prActice in Patients with non-valvular Atrial Fibrillation

DRKS00007912

UMIN000017011

Prolongation PREFER in AF PREvention oF thromboembolic events-European Registry in Atrial Fibrillation

DRKS00005996

Edoxaban Treatment in routiNe clinical prActice in Patients with Venous ThromboEmbolism

DRKS00007934

UMIN000024006

All Nippon AF In Elderly registry in Japan to study NVAF in elderly patients aged 75 years and older

UMIN000016387

Edoxaban Management In diagnostic and Therapeutic procedures - AF/VTE

NCT02950168

Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry

UMIN000024942

Through EDOSURE, we are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

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