LIBERATE
Research type
Research Study
Full title
A phase II, randomised, double-bLInd, placeBo-controllEd tRiAl To invEstigate the efficacy and safety of glenzocimab and the mechanism of inhibiting platelet GPVI as a treatment for ST-elevation myocardial infarction (LIBERATE)
IRAS ID
1005400
Contact name
Jonathan Townend
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2022-001054-32
Research summary
Glenzocimab is a medication that blocks thrombosis, which is the abnormal type of blood clotting that occurs during heart attacks and strokes. Unlike existing anti-blood clotting medications, glenzocimab is thought to have minimal effect on normal types of blood-clotting that prevent bleeding. The aim of this trial is to determine if glenzocimab reduces the damage caused by a heart attack in patients presenting with a big heart attack also known as ST-segment elevation Myocardial Infarction (STEMI).
Over 15 months, we plan to recruit 212 patients with STEMI from two centres in the UK (Birmingham and Sheffield). Patients will be randomised to receive either glenzocimab or placebo as soon as they arrive in hospital. Patients will receive otherwise standard care, including percutaneous coronary intervention, which is the emergency procedure that is used to unblock the blood vessels around the heart (coronary arteries). Patients will be closely monitored for any side effects and their condition will be monitored.
The aim of the study is to determine whether glenzocimab is a safe and effective treatment for large heart attacks. We will assess its effectiveness by determining whether it reduces heart damage, by measuring this using a heart scan called a cardiac MRI after 3 months.
We plan to recruit the first patient at the start of May 2023. Once the last patient has completed their last visit, the data collection will be closed and the data will be analysed. We anticipate trial report within 12 months of the last patient completing the trial. This will be the end of quarter three 2025.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0045
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion