BRIDGE

• Research type

  Research Study

• Full title

  Maintenance of platelet inhiBition with cangreloR after dIscontinuation of thienopyriDines in patients undergoing surGEry: The BRIDGE trial

• IRAS ID

  45602

• Sponsor organisation

  The Medicines Company

• Eudract number

  2008-001135-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  NCT00767507

• Research summary

  The BRIDGE study is designed to determine if the use of cangrelor IV infusion is safe in patients who are required to discontinue their oral thienopyridine therapy (a medication that inhibits platelet function) prior to coronary artery bypass graft surgery (CABG). Standard of care (SOC) medical guidelines recommend that patients discontinue this therapy (??washout?) between 5 and 7 days prior to the date of their surgery in order to minimize the risk of bleeding during the surgery and allow platelet function to return to normal. However, by discontinuing the therapy, the patient is placed at risk of having a heart attack or other “ischaemic event”. This study proposes the use of cangrelor to maintain that needed platelet inhibition during this “washout ”phase because the effects of cangrelor can be reversed by simply discontinuing the infusion 1 hour prior to surgery, allowing platelet function to return to normal after approximately 1 hour. In this study, patients will be randomized within 48 hours of taking their last dose of thienopyridine therapy to receive either cangrelor or placebo infusion. The purpose of placebo medication is to blind the study. Patients who receive cangrelor or placebo will be receiving additional medication above the SOC. Following a minimum of 48 hours up to a maximum of 7 days of study drug infusion, the study drug will be discontinued 1 to 6 hours prior to surgery and patients will undergo CABG surgery. At baseline, daily during the infusion and up to 24 hour post CABG, blood will be taken from the patients to analyze their level of platelet inhibition while on and off the study drug infusion. The results of this testing will be unknown until the end of the study. Patients will be followed as per SOC after surgery until 30 days post-surgery.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/21

• Date of REC Opinion

  21 Jun 2010

• REC opinion

  Further Information Favourable Opinion