REFINE CABG study
Research type
Research Study
Full title
A RandomizEd trial of two diFferent antIplatelet strategies in patieNts with acutE coronary syndromes planned for Coronary Artery Bypass Graft surgery - the REFINE CABG study
IRAS ID
1005625
Contact name
Robert Storey
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN17514416
Research summary
Most heart attacks are due to blood clots forming within the heart’s blood vessels. Two anticlotting medications, aspirin and ticagrelor, are used to treat heart attacks. Some people require open-heart surgery to bypass the blockages in their heart blood vessels. Because of the risk of bleeding associated with this, ticagrelor is usually stopped 5 days before surgery but this may delay surgery and is associated with a small risk of another heart attack as the ticagrelor effects wear off. Cytosorb is a device that is approved for removing ticagrelor from the bloodstream during heart surgery. In this study, people who are planned for bypass surgery following a heart attack and provide written consent will be randomised to one of two strategies: 50% will have standard treatment of stopping ticagrelor approximately 5 days before surgery and just continuing aspirin; and 50% of participants will take their last doses of ticagrelor and aspirin in the morning of the day before surgery, following which Cytosorb will be used to remove ticagrelor during surgery. Blood tests will be performed to study blood clotting and other properties at 4 time points: at randomisation; just before surgery; after patients come off the heart-lung machine during surgery; and 2-4 hours after surgery. A test known as skin bleeding time will also be performed at these time points, which involves pricking the skin on the forearm three times and measuring how long the bleeding lasts. Details of bleeding following surgery and other clinical events will be recorded. All face-to-face visits will be performed during the hospital stay and a single telephone follow-up will be performed at 30 days after surgery. Study recruitment will be performed at a single site and will continue until 40 participants have undergone surgery. The study will provide insights into a potential way of improving the experience and reducing the risks for patients who require open-heart surgery following a heart attack.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0142
Date of REC Opinion
29 Jul 2022
REC opinion
Further Information Favourable Opinion