A randomised study looking at ticagrelor therapy in STEMI patients

• Research type

  Research Study

• Full title

  A 30 day international, randomized, parallel-group, double-blind, placebocontrolled phase IV study to evaluate efficacy and safety of pre-hospital vs. in-hospital initiation of ticagrelor therapy in STEMI patients planned for PCI

• IRAS ID

  71988

• Sponsor organisation

  AstraZeneca

• Eudract number

  2011-000214-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  TBC

• Research summary

  Ticagrelor, given with aspirin, is an approved medicine for the prevention of atherothrombotic events (blood clots) in adult patients with Acute Coronary Syndromes including ST Elevation Myocardial Infarction (STEMI) ?? a type of heart attack. It is licensed for use in patients who are treated with Percutaneous Coronary Intervention (PCI), a procedure that aims to open the blocked artery to restore blood flow to the affected heart tissue. Patients are initially managed by ambulance personnel in pre hospital settings. They are then transferred into a catheterisation room to undergo a PCI.The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI.All patients who agree to take part in this study will receive a loading dose of ticagrelor as antiplatelet therapy prior to PCI. They will be assigned by chance to be given ticagrelor or placebo in the ambulance and placebo or ticagrelor on arrival at the hospital. After their PCI all patients will be treated with ticagrelor twice a day for 30 days in combination with aspirin. This active treatment period will then be followed by a safety monitoring period of 7 days.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  11/NE/0122

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion