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), registry and non-randomized clinical studies, 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)
  • STABLED Study (STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation) in Japan
  • ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation, an investigator initiated phase III study)

Randomized-controlled Clinical trials in AF and VTE

Clinical Setting First Data Disclosure
Engage AF TIMI48 Non valvular atrial fibrillation patients

Presented at AHA 2013
NCT00781391

Hokusai VTE VTE patients

Presented at ESC 2013
NCT00986154

ENSURE-AF AF patients undergoing electrical cardioversion

Presented at ESC 2016
NCT02072434

ELIMINATE-AF AF patients undergoing catheter ablation

Presented at EHRA 2019
NCT02942576

ENTRUST-AF PCI AF patients undergoing PCI

Presented at ESC 2019
NCT02866175

ENVISAGE-TAVI AF AF patients undergoing transcatheter aortic valve implantation

(Still ongoing)
NCT02943785

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

Presented at ESC 2020
NCT02801669

Hokusai VTE CANCER Patients with VTE associated with cancer

Presented at ASH 2017
NCT02073682

STABLED study Non valvular AF patients with history of stroke

(Still ongoing)
jRCTs031180249

ENRICH-AF AF patients with history of intracranial hemorrhage

(Still ongoing)
NCT03950076

In addition, EDOSURE’s global and regional registry and non-randomized clinical studies provide important real-world and clinical data about the use of edoxaban and other oral anticoagulants in everyday practice, these 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
  • RYOUMA Registry in Japan
  • KYU-RABLE in Japan
  • BPV-AF Registry in Japan

Registry and non-randomized clinical studies

ETNA-AF Global Edoxaban Treatment in routiNe clinical prActice in Patients with non-valvular Atrial Fibrillation
DRKS00007912
UMIN000017011
PREFER in AF Prolongation Prolongation PREFER in AF PREvention oF thromboembolic events-European Registry in Atrial Fibrillation
DRKS00005996
ETNA-VTE Global Edoxaban Treatment in routiNe clinical prActice in Patients with Venous ThromboEmbolism
DRKS00007934
UMIN000016387
ANAFIE All Nippon AF In Elderly registry in Japan to study NVAF in elderly patients aged 75 years and older
UMIN000024006
EMIT-AF/VTE Edoxaban Management In diagnostic and Therapeutic procedures - AF/VTE
NCT02950168
Cancer-VTE Registry Venous Thromboembolism (VTE) in Cancer Patients; a Multicenter Prospective Registry in Japan
UMIN000024942
KYU-RABLE STUDY Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation
UMIN000029693
RYOUMA REGISTRY Real world ablation therapy with anticoagulants in management of atrial fibrillation in Japan
UMIN000026092
BPV AF Registry Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve in Japan
UMIN000034198
UMIN000034485

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.