Extrait

Background and study aims Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood. The fatty deposits cause the arteries to narrow, eventually reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI). In PCI, a balloon is inserted into the artery supplying blood to the heart to open it up where it has narrowed. A small mesh tube called a stent is then left in the artery once the balloon is removed to permanently hold the artery open and allow more blood to flow to the heart. One of the risks of PCI stent insertion, and also in CAD, is the formation of blood clots that can block the arteries, stopping or reducing blood flow and causing a heart attack. Small blood cells called platelets are involved in the formation of the blood clots that cause heart attacks. Antiplatelet drugs (e.g. aspirin) are given to patients with CAD to reduce the risk of a clot forming and causing a heart attack. In a recent large clinical trial (the PLATO study), it was shown that heart attack patients treated with the new antiplatelet drug ticagrelor had fewer heart attacks compared to the current standard drug treatment clopidogrel. The aim of this study is to compare three different treatment strategies for prescribing these antiplatelet drugs to patients with stable CAD following PCI stent surgery. Who can participate? Adults with stable CAD on a waiting list for PCI stent implantation. What does the study involve? All participants have standard PCI stent surgery. Participants are then randomly allocated into one of three groups. Those in group 1 (intervention group) are given the drug clopidogrel. Those in group 2 (intervention group) are given dose 1 of the drug ticagrelor. Those in group 3 (intervention group) are given dose 2 of the drug ticagrelor. Participants take the medication for 30 days and have blood tests and meet with the research team during that time to assess the effects of each medication strategy. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? University of Sheffield (UK) When is the study starting and how long is it expected to run for? June 2015 to December 2016 Who is funding the study? AstraZeneca UK Limited (UK) Who is the main contact? Mrs C Bridge

Critère d'inclusion

• Atherothrombosis

Liens

• isrctn
• ictrp