How Effective are Antithrombotic Therapies in Primary PCI: HEATppci v1

• Research type

  Research Study

• Full title

  HEAT-PPCI - How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention - A randomised controlled trial to compare unfractionated heparin versus bivalirudin in the treatment of patients with a clinical diagnosis of ST-segment elevation myocardial infarction, for planned management with primary PCI

• IRAS ID

  89034

• Contact name

  Rod Stables

• Sponsor organisation

  Liverpool Heart and Chest Hospital

• Eudract number

  2011-005273-23

• Research summary

  In ST-elevation myocardial infarction (STEMI) or heart attack, often an artery is blocked and the blood supply to parts of the heart is completely interrupted. The preferred treatment option is called Primary Percutaneous Coronary Intervention (PPCI) or primary angioplasty. This is an urgent treatment to restore blood flow to the heart by opening the blocked artery using small balloons and stents. During PPCI - in every case - we use drugs to prevent blood clotting at the treatment site. Two anti-clotting drugs, Heparin and Bivalirudin, are in widespread and routine use worldwide as well as in our hospital. Both agents have been studied and are known to be safe and effective. Currently we do not know for sure if one drug may have some slight advantage over the other in the setting of PPCI. Hence, we are comparing Heparin and Bivalirudin to see if there is any difference in the treatment of heart attacks and reducing complications of treatment such as bleeding. This will help us choose the better medication for patients requiring PPCI in the future. We will recruit approximately 1800 patients undergoing PPCI at Liverpool Heart and Chest Hospital over a period of 28 months. These patients will be randomly allocated into one of the two groups either receiving heparin or bivalirudin. All other treatments will be the same for both groups according to standard PPCI treatments. Both groups of patients will have a blood sample taken during the procedure to assess tests of platelets and blood clotting. Platelets play a major role in blood clotting and our study will compare the effects of heparin and bivalirudin on platelet function. Patients will be followed up for 28 days to look for any difference between the two groups for heart attacks, additional angioplasty procedures, stroke and death.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0779

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Favourable Opinion