Cleerly has announced the TRANSFORM trial a randomised trial that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease.
The trial will aim to demonstrate that a personalised care strategy based on an analysis by Cleerly’s AI-based platform is better than usual care based on traditional cardiovascular risk factors for the primary prevention of cardiovascular events.
The trial sees Cleerly partnering with a number of organisations including AGEPHA Pharma, CPC Clinical Research, Esperion Therapeutics, Heartbeat Health and Lexicon Pharmaceuticals.
The trial will be led by chair Deepak L Bhatt (Icahn School of Medicine at Mount Sinai, New York, USA), co-chair David Maron (Stanford University School of Medicine, Stanford, USA) and Marc Bonaca (University of Colorado School of Medicine, Aurora, USA). Additionally, the American Heart Association will be providing educational materials.
“We are thrilled to start the TRANSFORM trial, which we believe will be a landmark study to demonstrate how a personalised care strategy, fuelled by AI, can revolutionise the way we think about prevention of cardiovascular events,” said James K Min, founder and CEO of Cleerly. “By focusing on the individual’s actual coronary artery disease, rather than just risk factors, we aim to prevent heart attacks. I look forward to the progression of this trial with our partners and the results in coming years.”
TRANSFORM will enrol patients at 100‒200 sites across the USA and treat atherosclerosis in patients with no symptoms or history of heart disease to reduce myocardial infarction (MI). The trial will utilise Cleerly’s investigational plaque staging system in the experimental arm to inform treatment and medication decisions made by providers.
Participants will be randomly assigned to the personalised care strategy or to usual care, and all participants will undergo a coronary computed tomography angiography (CCTA) scan.
Patients assigned to usual care will be treated based on atherosclerotic cardiovascular disease (ASCVD) risk factors, while those in the personalised care strategy will have an investigational coronary artery disease (CAD) plaque staging system report for both baseline and at 24-months, and CCTA results will be provided to the central cardiologist-led team for discussion and care planning with the patient.
“As study chair and lead investigator, I am excited to embark on the TRANSFORM trial, which we hope will showcase the transformative potential of a personalised care strategy empowered by CCTA scans and AI,” said Bhatt. “This trial provides us the opportunity to revolutionise cardiovascular event prevention and ultimately save lives from heart disease. I eagerly anticipate the collaboration with all the valued partners across this trial and the forthcoming results to help us shape the future of cardiovascular care.”