Boehringer Ingelheim and Eli Lilly have partnered with the Duke Clinical Research Institute (DCRI) to conduct an EMPACT-MI clinical trial of Jardiance (empagliflozin) to prevent heart failure.
The study will assess the drug’s ability to improve outcomes and prevent heart failure in adults with or without diabetes who have experienced acute myocardial infarction or heart attack.
DCRI will work with the companies to conduct, analyse and report the trial, while Boehringer and Lilly provide funding.
Jardiance is a prescription drug indicated for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. It is also used to decrease the risk of cardiovascular death in type 2 diabetes patients who have known cardiovascular disease.
The randomised, blinded, placebo-controlled, multi-centre trial will assess the safety and efficacy in adults hospitalised with an acute myocardial infarction. It will enrol about 3,300 patients in at least 16 countries.
EMPACT-MI is part of the EMPOWER programme, a large-scale clinical trial scheme evaluating Jardiance in patients with cardio-renal-metabolic conditions.
Eli Lilly Product Development vice-president Jeff Emmick said: “The EMPACT-MI trial is part of our broad and comprehensive clinical development programme, which aims to explore how Jardiance can improve health outcomes and fill therapeutic gaps for a broad range of patients suffering from cardio-renal-metabolic conditions.”
The primary endpoint of the EMPACT-MI trial is the effect of the drug on all-cause mortality and hospitalisation for heart failure. EMPACT-MI is a pragmatic trial, which focus on the link between therapies and outcomes in a real-world setting.
DCRI will contribute via its experience in pragmatic trials. It will deploy new trial elements, including remote follow-up and a focused data collection method.