The TEMPLATE Study
Research type
Research Study
Full title
A Randomised Controlled Trial Investigating the Pharmacodynamic Effect of Ticagrelor Monotherapy on Platelet Reactivity in Patients with Coronary Artery Disease: The TEMPLATE Study
IRAS ID
134909
Contact name
Andrew Mumford
Contact email
Sponsor organisation
University Hospitals NHS Foundation Trust
Eudract number
2013-002734-20
ISRCTN Number
ISRCTN84335288
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
A blocked or seriously narrowed coronary artery will cause chest pain during exercise or a heart attack when blood supply to the heart muscle is interrupted. This is usually treated using a procedure called Percutaneous Coronary Intervention (PCI) in which a small wire is inserted into the coronary artery and a small balloon is inflated to open up the blockage. Sometimes a small mesh tube called a stent is left in place to keep the vessel open. Although this is a very effective treatment, there is an increased risk of blood clots forming on the stent and causing another blockage in the coronary artery. Abnormal clot formation on coronary stents is caused by blood platelets sticking to the stent and then undergoing activation. In order to prevent this, patients are treated routinely with drugs that prevent platelet activation (anti-platelet drugs) such as aspirin. For the period of highest risk of clot formation in the first 12 months after stent insertion, aspirin is usually given in combination with clopidogrel which is a different kind of anti-platelet drugs called an ‘ADP receptor blocker’. It has been known for several years that aspirin in combination with clopidogrel is more effective at preventing clots after stent insertion than aspirin used alone. More recently, a more powerful ADP receptor blocker called ticagrelor has been developed. Ticagrelor in combination with aspirin offers better protection against clot formation than clopidogrel in combination with aspirin. Therefore, ticagrelor in combination with aspirin is now given to some groups of patients after stent insertion.
Since ticagrelor inhibits platelet activation more effectively than clopidogrel, it has now been questioned whether prescribing aspirin in addition to ticagrelor offers any extra benefit to patients. If ticagrelor given alone caused the same level of platelet inhibition as ticagrelor in combination with aspirin then this could mean that patients don’t need to be given aspirin at all, and could avoid side effects such as stomach bleeding. This research study aims to look in detail at blood platelets using several different tests to compare how well platelets are inhibited using ticagrelor given either with, of without additional aspirin. The study will be performed using platelets given by participants more than 12 months after stent insertion when the risk of clot formation is very low. The most important comparison will be between platelets from patients receiving ticagrelor alone and from patients receiving ticagrelor in combination with aspirin. However, we will also compare the effects of ticagrelor on platelets with the effects of other common combinations of anti-platelet drugs. The study will give important information about the likely efficacy of longer term treatment with ticagrelor alone, started soon after stent insertion.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1309
Date of REC Opinion
23 Oct 2014
REC opinion
Further Information Favourable Opinion