COMUNICADO: Daiichi Sankyo Initiates ENVISAGE-TAVI AF Study Investigating Once-Daily LIXIANA®▼ (edoxaban) in Patients with Atrial Fi

 

COMUNICADO: Daiichi Sankyo Initiates ENVISAGE-TAVI AF Study Investigating Once-Daily LIXIANA®▼ (edoxaban) in Patients with Atrial Fi

Publicado 27/04/2017 15:02:43CET

MUNICH, April 27, 2017 /PRNewswire/ --


- ENVISAGE-TAVI AF is the first study to evaluate the effects of a novel oral
anticoagulant on clinical outcomes exclusively in atrial fibrillation patients
following successful transcatheter aortic valve implantation         
- Study adds to the growing Edoxaban Clinical Research Programme (ECRP) evaluating its
use in a broad range of cardiovascular conditions, patient types and clinical
settings     

Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") today announced that the first patient has been enrolled into the ENVISAGE-TAVI AF study. The multinational, randomised phase 3b study will evaluate a treatment regimen based on the company's oral, once-daily direct factor Xa-inhibitor edoxaban (known by the brand name LIXIANA(R) outside the US and SAVAYSA(R) in the US) against a vitamin K antagonist based regimen, with or without antiplatelet therapy, in patients with atrial fibrillation (AF) following successful transcatheter aortic valve implantation (TAVI). The study will investigate the incidence of net adverse clinical events (NACE), including the composite of all-cause death, myocardial infarction (MI), ischaemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition). Approximately 1,400 patients will be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across Europe, the United States and Canada.[1]

"ENVISAGE-TAVI AF is a very important study because it will provide the first clinical evidence comparing the safety and efficacy of an edoxaban-based versus a VKA-based regimen in non-valvular AF patients with indication for chronic oral anticoagulation after successful TAVI in a sufficiently powered study. In this study, edoxaban will be used with the approved dosage regimen for stroke prevention in atrial fibrillation," said George Dangas, MD, PhD, Professor of Medicine, Mount Sinai School of Medicine and co-principal study investigator.

Transcatheter aortic valve implantation (TAVI) has become an increasingly frequent procedure to treat aortic stenosis.[2] Aortic stenosis is a progressing disease, and may turn into a life threatening condition.[3] In patients undergoing a TAVI procedure, AF is a frequent comorbidity which requires chronic oral anticoagulation therapy.[4],[5]

"At present, ENVISAGE-TAVI AF is the only study of patients undergoing TAVI designed to compare exclusively non-valvular AF patients on a novel oral anticoagulant regimen against a VKA-based regimen," said Nicolas M. van Mieghem, MD, PhD, Erasmus University of Rotterdam and co-principal investigator.

"ENVISAGE-TAVI AF will add to the growing body of evidence in the Edoxaban Clinical Research Programme, providing unique insights into the potential benefit of edoxaban in atrial fibrillation patients undergoing TAVI procedures, a high-risk population," said Hans J. Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo.

To access the latest news, media backgrounders, images, and videos please visit http://pressportal.lixiana.com. Please note that the press portal is not intended for UK media.

About ENVISAGE-TAVI AF      

EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation - in Atrial Fibrillation (ENVISAGE-TAVI AF) is a prospective, randomised, open-label, blinded endpoint evaluation, parallel-group phase 3b study, evaluating the efficacy and safety of once-daily edoxaban against a regimen of a vitamin K antagonist, with or without antiplatelet therapy, in AF patients following successful transcatheter aortic valve implantation (TAVI). The primary efficacy endpoint is incidence of net adverse clinical events (NACE), i.e., the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition). The primary safety endpoint is major bleeding (ISTH definition). Approximately 1,400 patients will be enrolled in ENVISAGE-TAVI AF from 200 clinical sites across Europe, the United States and Canada. Edoxaban will be used with the approved dosage regimen for stroke prevention in AF in each country.[1]

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02943785.

About Atrial Fibrillation     

AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.[6]

AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.[7] An estimated 8.8 million Europeans suffered from AF in 2010, and this figure is expected to at least double over the next 50 years.[8] Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.[9] One in five of all strokes are as a result of AF.[5]

About Edoxaban     

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed in Japan, the U.S., South Korea, Hong Kong, Taiwan, Thailand, Switzerland, the U.K., Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria, Portugal, and other European countries.

The edoxaban Summary of Product Characteristics can be viewed here: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf .

About Edoxaban Clinical Research Programme (ECRP)     

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The Edoxaban Clinical Research Programme includes multiple RCTs (randomised, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the Edoxaban Clinical Research Programme, including completed, ongoing and future research.

The RCTs include:


- 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)

(CONTINUA)

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