P3-AMI Antiplatelet Trial
Research type
Research Study
Full title
Pharmacokinetics and Pharmacodynamics of Platelet P2Y12 Inhibitors in Patients Undergoing Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction: A Pilot Study
IRAS ID
158302
Contact name
James M. Cotton
Contact email
Sponsor organisation
The Royal Wolverhampton NHS Trust
Eudract number
2014-004238-25
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
Major heart attacks are caused by a numerous factors, including sudden clot formation in a coronary artery leading to a blockage and heart muscle death. The clots are largely made of sticky clotting blood cells (platelets). A patient having a major heart attack is treated with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon are used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep the artery open. Aspirin, and one of two other anti-platelet drugs (prasugrel or ticagrelor) are given prior to PPCI to prevent further clots formation. Both anti-platelet drugs are taken in tablet form and in healthy stable patients these drugs take at least 30 min to 2 hours to exert an adequate effect. Often PPCI procedures are performed well within this timescale. It is possible that having a major heart attack limits the bodies ability to absorb the drugs also.
In this study, patients with major or minor heart attacks will be given either prasugrel or ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample will be taken at first balloon inflation to reopen the blocked artery, then after 20 minutes, 60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected to a variety of tests to determine anti-platelet drug activity .
This study will identify which of the two agents used are working effectively during PPCI, given the very short timescales involved. It will also show if patients with major heart attacks absorb the drugs less well than patients with less severe heart attacks. In the future it might be that an intravenous agent will be more valuable in the setting of PPCI.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1236
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion