The Icahn School of Medicine at Mount Sinai (New York, USA) has received a US$2 million grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to study which therapy is optimal for treating spontaneous coronary artery dissection (SCAD).
Mount Sinai will use the funding for a one-year feasibility phase of the US portion of a major international clinical trial—SCAD ALIGN—to determine whether aspirin alone or a more intensive combination of blood-thinning medications is better for treating this condition.
Led by the Clinical Trial Center of Mount Sinai Fuster Heart Hospital and the Institute for Transformative Clinical Trials, the study aims to provide evidence that can inform future treatment recommendations for patients with SCAD worldwide and improve outcomes.
Following a successful feasibility phase, Mount Sinai will receive approximately US$14 million over seven years from NIH to launch a larger US portion of the same clinical trial.
“Because SCAD disproportionately affects women, often at a relatively young age and without the traditional warning signs of heart disease, answering this question is particularly important. Our goal is to determine which treatment provides the best protection while exposing patients to the least unnecessary risk,” says Roxana Mehran, Mount Sinai professor in cardiovascular clinical research and outcomes. Mehran is a principal investigator for the trial’s clinical coordinating centre.
“SCAD is a very different disease from the type of heart attack we encounter most often, yet many of the treatments we use today have been adopted from studies conducted in other patient populations. This trial gives us an opportunity to generate the rigorous evidence that patients with SCAD and their physicians have been waiting for,” says Deepak L Bhatt, director of Mount Sinai Fuster Heart Hospital and a principal investigator of the clinical coordinating centre.
After a typical heart attack, patients are often treated with antiplatelet medications to make platelets in the blood less likely to stick together and form clots. Because SCAD is caused by a problem within the artery wall rather than cholesterol buildup, doctors do not have clear evidence about the best treatment. Many treatments currently used for these patients were developed for more common types of heart attack caused by cholesterol buildup. These treatments have not been adequately tested in a large, randomized trial specifically for SCAD. This study is designed to provide evidence directly relevant to these patients.
SCAD-ALIGN will compare a moderate antiplatelet strategy of aspirin alone for three months with a more intensive strategy of dual antiplatelet therapy (DAPT) for three months followed by nine months of single antiplatelet therapy. Researchers plan to enrol roughly 3,500 patients internationally (roughly 500 in the USA at 60 sites) and evaluate major cardiovascular outcomes, including cardiovascular death, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, stroke, transient ischemic attack, and bleeding.
SCAD-ALIGN was endorsed by the Multinational Clinical Trials Initiative of the Global Cardiovascular Research Funders Forum (GCRFF). The global collaboration includes investigators and funding organizations from the USA, Germany, UK, Canada, the Netherlands, Denmark, Sweden, Spain, Australia, New Zealand, and other participating countries, with additional participation from centres in South America.
