A Randomised Controlled Trial Investigating the Pharmacodynamic Effect of Ticagrelor Monotherapy on Platelet Reactivity in Patients with Coronary Artery Disease: The TEMPLATE Study
Sponsor: University Hospitals Bristol
REC Number: 14/SC/1309
The TEMPLATE study is a single centre, open-label randomised controlled trial of the investigational medicinal product ticagrelor. Patients with blocked or seriously narrowed coronary arteries are treated with a procedure called Percutaneous Coronary Intervention (PCI) in which a stent is inserted to open up the blockage in the coronary artery. Patients are usually prescribed Dual Antiplatelet Therapy (DAPT) with aspirin and clopidogrel (ADP blocker) course following their PCI. The use of two different anti-platelet agents helps ensure that platelets are completely inhibited and thereby, are less likely to contribute to abnormal clot formation in the coronary stent.
A new anti-platelet drug called ticagrelor is now available and is given with aspirin to some patients after a stent procedure. Ticagrelor is a more powerful and reliable ADP blocker than clopidogrel, and is replacing clopidogrel in some patient groups. There is emerging evidence from healthy volunteer studies that ticagrelor used alone may be sufficient to strongly inhibit platelets, without the need for additional aspirin. The TEMPLATE study aims to find out if ticagrelor alone is as good as taking ticagrelor and aspirin together at inhibiting platelets, in patients who have had a PCI.
The study population is patients at the end of a DAPT course with clopidogrel and aspirin following a PCI, and who are due to revert aspirin monotherapy as part of standard clinical care at 6 to 12 months after PCI. Patients who take part in the trial will be randomised to receive either aspirin and ticagrelor or ticagrelor alone for a 4 week interval prior to reverting to aspirin alone. Blood samples for detailed analysis of the extent of platelet inhibition will be taken at three time-points, whilst patients are receiving different combinations of anti-platelet therapy. The main analysis will compare the extent of platelet inhibition between the patient groups receiving ticagrelor alone compared to those receiving ticagrelor plus aspirin.
Chief Investigator: Dr Andrew Mumford