DUAL antithrombotic therapy with dabigatran etexilate (RE-DUAL PCI)

• Research type

  Research Study

• Full title

  A prospective Randomised, open label, blinded endpoint (PROBE)study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting.

• IRAS ID

  159926

• Contact name

  Mick Ozkor

• Contact email

  mick.ozkor@uclh.nhs.uk

• Eudract number

  2013-003201-26

• Duration of Study in the UK

  2 years, 7 months, 17 days

• Research summary

  This study is a prospective Randomised, open label, blinded endpoint (PROBE) study. The aim of this study is to compare two different treatment regimens: 1. The anticoagulant dabigatran etexilate (Pradaxa®, Prazaxa®) when combined with one antiplatelet agent, either clopidogrel (Plavix®) or ticagrelor (Brilinta®, Brilique®) or 2)The anticoagulant warfarin when combined with two antiplatelet agents (aspirin and either clopidogrel or ticagrelor).
  About 8500 patients will participate in this study at about 700 research centres around the world. Each patient's participation in this study is expected to last between 7 months and up to approximately two and a half years and will involve approximately 6 to 14 study visits.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  14/LO/2011

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Further Information Favourable Opinion