An announcement on partners to collaborate in the TRANSFORM trial was made today during the American Heart Association’s (AHA) 2023 Scientific Sessions. Data from the randomized control trial will advance evidence for evaluation and treatment of heart disease by studying actual disease: atherosclerosis. Image courtesy: Getty Images
November 11, 2023 — An announcement on partners to collaborate in the TRANSFORM trial was made today during the American Heart Association (AHA) 2023 Scientific Sessions. TRANSFORM is a randomized control trial – sponsored by Cleerly – that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease. TRANSFORM aims to prove that a personalized care strategy based on a Cleerly analysis of a patient’s actual disease state is better than traditional care based on typical risk factors for the primary prevention of cardiovascular events.
For its part, Cleerly, as trial sponsor, is providing Cleerly software to analyze patients’ coronary computed tomography angiography (CCTA) scans and Cleerly’s investigational plaque staging system, according to a written statement detailing the study. For the TRANSFORM trial Cleerly is partnering with:
American Heart Association (AHA) - Providing educational materials (Life’s Essential 8) as part of Cleerly’s membership in the Technology and Innovator’s Network
AGEPHA Pharmaceuticals - Providing in-kind support of LODOCO, which reduces coronary inflammation
CPC Clinical Research - Academic research organization serving as the clinical, data and statistical coordination center for the trial
Esperion Therapeutics - Providing in-kind support of NEXLIZET (bempedoic acid and ezetimibe) Tablet, which reduces low-density lipoprotein (LDL) cholesterol in adults
Heartbeat Health - A virtual cardiology provider for the trial
Lexicon Pharmaceuticals - Providing in-kind support of Inpefa, which significantly reduces the risk of death and hospitalization/urgent visits to the doctor for heart failure
Study Chair Deepak Bhatt, MD, MPH, FACC, FAHA, FESC, MSCAI, Director of Mount Sinai Heart; Valentin Fuster, MD, PhD, President of Mount Sinai Heart, Physician-in-Chief, and Professor of Cardiovascular Medicine, Icahn School of Medicine at Mount Sinai Health System
Co-Chair Marc Bonaca, MD, MPH, FAHA, FACC, Executive Director of CPC Clinical Research, William R. Hiatt Endowed Chair in Cardiovascular Research, Professor of Medicine; Cardiology & Vascular Medicine and Director of UCSM Vascular Research, University of Colorado School of Medicine
“We are thrilled to start the TRANSFORM trial, which we believe will be a landmark study to demonstrate how a personalized care strategy, fueled by AI, can revolutionize the way we think about the prevention of cardiovascular events,” said James K. Min, MD, FACC, FESC, MSCCT, Founder and CEO of Cleerly. Min added, “By focusing on the individual’s actual coronary artery disease, rather than just risk factors, we aim to prevent heart attacks. We look forward to the progression of this trial with our partners and the results in coming years.”
“Esperion is excited to collaborate with these nationally recognized partners on this groundbreaking and revolutionary study,” said JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of Esperion. “Cardiovascular disease remains the number one killer of men and women worldwide, so it’s critical to focus on prevention, and utilizing AI combined with observation of the disease itself is a progressive approach to preventing cardiovascular events before they happen in the first place,” added Foody.
TRANSFORM will enroll patients at 100-200 sites across the U.S. and treat atherosclerosis in patients with either no symptoms or a history of heart disease in order to reduce myocardial infarction (heart attacks). The trial will utilize Cleerly’s investigational plaque staging system in the experimental arm to inform treatment and medication decisions made by providers. TRANSFORM trial recruitment is scheduled to close in fall 2025 and results can be expected in late 2028.
“The TRANSFORM trial brings together the power of AI for staging coronary disease and the well-documented benefits of advanced lipid lowering, anti-thrombotic, anti-inflammatory and cardiometabolic medications to create an individual care plan for patients at risk for cardiovascular events,” said Udo Hoffmann, MD, MPH, Chief Scientific Officer of Cleerly. “We are excited to partner with academic leaders, professional societies, pharmaceutical companies and healthcare providers to provide scientific proof for a new paradigm in the primary prevention of cardiovascular disease that is similar to what has been established for decades in the prevention of cancer.”
Participants will be randomly assigned to the personalized care strategy or to traditional care, and all participants will undergo a CCTA scan at baseline and at 24 months. Patients assigned to traditional care will be treated by their primary care providers using available treatment guidelines, and CCTA results will be provided at the end of the study. Separately, those assigned to the personalized 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 personalized care strategy empowered by CCTA scans and AI,” said Deepak L. Bhatt, MD, MPH, FACC, FAHA, FESC, MSCAI, Director of Mount Sinai Heart and Dr. Valentin Fuster Professor of Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai. Bhatt further noted, “This trial provides us the opportunity to revolutionize cardiovascular event prevention and ultimately save lives from heart disease. I eagerly anticipate the collaboration with all valued partners across this trial and the forthcoming results to help us shape the future of cardiovascular care.”
Follow more of DAIC’s AHA news coverage here.