ARTESiA: Apixaban in patients with device-detected sub-clinical AF

• Research type

  Research Study

• Full title

  APIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM IN PATIENTS WITH DEVICE-DETECTED SUB-CLINICAL ATRIAL FIBRILLATION.

• IRAS ID

  180225

• Contact name

  Jeff Healey

• Contact email

  jeff.healey@phri.ca

• Sponsor organisation

  Hamilton Health Sciences Corporation

• Eudract number

  2014-001397-33

• Clinicaltrials.gov Identifier

  NCT01938248

• Duration of Study in the UK

  4 years, 2 months, 31 days

• Research summary

  Globally, there are millions of patients being treated with pacemakers and implantable cardioverter defibrillators (ICD). These devices, in addition to treating tachycardia or bradycardia (fast or slow heart rates), also continuously monitor the heart's electrical activity and can diagnose sub­clinical atrial fibrillation (SCAF). These are relatively brief, asymptomatic episodes of atrial fibrillation that would not be detected unless the patient had the implantable device (pacemaker or ICD). The clinical significance of SCAF is now better understood as a result of the ASSERT study which reported that patients with SCAF ≥ 6 minutes had a 2.5­-fold increased risk of stroke. In patients found to have SCAF who also had a CHADS2-VASc score of 4, the risk of stroke in ASSERT was 2.75% per year. It is unknown if any treatments are useful for patients with SCAF.

  For patients with clinically-detected atrial fibrillation, the use of oral anticoagulation results in a positive risk benefit; however, for patients in whom the only arrhythmia is asymptomatic device-detected atrial fibrillation the risk benefit from oral anticoagulation is uncertain. Current guidelines do not routinely recommend oral anticoagulation for device-detected atrial fibrillation. A randomized clinical trial of oral anticoagulation is needed to assess the effectiveness and safety in these patients.

  ARTESiA will enroll 4000 patients with at least one episode of SCAF between 6 minutes and 24 hours. Patients must be free of clinical atrial fibrillation and have a CHADS­2-VASc score > 3. Patients will be randomized to receive either the oral anticoagulant, apixaban or to receive aspirin and will be followed for the primary outcome of ischemic stroke or systemic embolism.

  ARTESiA will provide a clear measure of the efficacy and safety of apixaban in patients with pacemakers and defibrillators who have SCAF and will provide clinicians with important guidance for this common problem.
  

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  15/LO/1119

• Date of REC Opinion

  19 Aug 2015

• REC opinion

  Further Information Favourable Opinion