1160.71 RELY-ABLE

• Research type

  Research Study

• Full title

  RELY-ABLE 1160.71 - Long Term Multi-center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation Who Completed the RELY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

• IRAS ID

  6713

• Contact name

  Bohehringer Ingelheim Study Co-ordinator

• Sponsor organisation

  Boehringer-Ingelheim Limited

• Eudract number

  2008-005248-17

• ISRCTN Number

  Not applicable

• Research summary

  The RELY-ABLE trial is looking at the long-term safety of the investigational drug dabigatran, in patientsAtrial Fibrillation who have already received dabigatran in the RE-LY trial. Dabigatran is a blood thinning compound and works by preventing the formation of blood clots within the body and heart. Atrial fibrillation is an irregular and disturbed heart rhythm and is the most common heart condition occurring in about 1% in those under 60 years old, and in about 6% of those over 80 years old. This condition can lead to blood clots being formed within the heart; these clots, or pieces of the clot, have the potential to block arteries (a type of blood vessel) within the brain causing stroke and possibly death. Suitable patients will have already received dabigatran in, and successfully completed, the RE-LY trial. patients will receive dabigatran for up to 28 months, or until dabigatran becomes approved and licensed in the UK forestroke prevention in patients with Atrial Fibrillation. patients will attend for trial visits every 4 to 5 months. The study will also comprise of an information feedback component to inform patients and investigators of possible opportunities to improve patient healthcare through following best management practices.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/153

• Date of REC Opinion

  6 Nov 2008

• REC opinion

  Further Information Favourable Opinion