Edoxaban treatment versus VKA in patients with AF undergoing PCI

• Research type

  Research Study

• Full title

  Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist-based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement(EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI - ENTRUST AF-PCI).

• IRAS ID

  215485

• Contact name

  Richard Anderson

• Contact email

  Richard.Anderson@wales.nhs.uk

• Sponsor organisation

  Daiichi Sankyo Europe GmbH

• Eudract number

  2016-002683-14

• Clinicaltrials.gov Identifier

  NCT02866175

• Clinicaltrials.gov Identifier

  16/WM/0464, West Midlands - Edgbaston

• Duration of Study in the UK

  2 years, 1 months, 31 days

• Research summary

  The optimal antithrombotic (‘blood thinning’) therapy in patients with atrial fibrillation following stenting of an artery close to the heart (coronary artery) is unknown at this time and is the subject of this investigation.

  There are two main types of blood thinners. Anticoagulants, such as edoxaban or vitamin-K antagonists (VKA), lengthen the time it takes to form a blood clot. Antiplatelet drugs, such as aspirin and so called P2Y12 inhibitors, prevent blood cells called platelets from clumping together to form a clot. Anticoagulants are typically used in patients with atrial fibrillation, a combination of aspirin and a P2Y12 inhibitor in patients following coronary artery stenting.

  Edoxaban has been developed as an alternative to VKA and has already been allowed for clinical use in European countries for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, high blood pressure, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA).

  In this study, edoxaban will now be given to patients who have atrial fibrillation AND have undergone a successful coronary artery stenting. Edoxaban in combination with P2Y12 will be compared to a VKA in combination with aspirin and a P2Y12 inhibitor for safety towards bleeding and efficacy towards thrombotic complications like stroke.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  16/WM/0464

• Date of REC Opinion

  13 Dec 2016

• REC opinion

  Further Information Favourable Opinion