STEEL PCI
Research type
Research Study
Full title
Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI)
IRAS ID
167117
Contact name
Robert Storey
Contact email
Sponsor organisation
Sheff REC - Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2014-004783-38
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood, causing the arteries to narrow and reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI) in which a balloon is inserted into the artery supplying the heart to open up the artery where it has narrowed. A stent is then left in the artery once the balloon is removed to hold the artery open and allow more blood to flow to the heart. One of the risks of this procedure, as in CAD itself, is the formation of blood clots that then block the arteries, stopping or reducing blood flow and causing a heart attack.
Platelets are small blood cells involved in the formation of 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 in the future and causing a heart attack. In a recent large clinical trial (PLATO study), it was shown that heart attack patients treated with a new antiplatelet medication (ticagrelor) had fewer later heart attacks compared to the current standard treatment (clopidogrel). The STEEL-PCI study is comparing three different strategies for prescribing antiplatelet medication to patients with stable CAD who have a PCI.
Patients on waiting list for PCI who meet the study inclusion/exclusion criteria will be invited to participate. Patients will have their PCI as normal but be randomised to take one of three different medication strategies, either clopidogrel or one of two doses of ticagrelor. Patient will 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.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1274
Date of REC Opinion
23 Dec 2014
REC opinion
Further Information Favourable Opinion