Aurora St. Luke’s Medical Center in Milwaukee has joined a large worldwide study to determine how well a new investigational self-administered drug can treat a heart attack.
“Despite general advances in the treatment of a heart attack, also known as an acute myocardial infarction (AMI), there is still an enormous need for new treatments in the timeframe between when symptoms first appear and when a patient arrives at a hospital and receives medical treatment,” said interventional cardiologist M. Fuad Jan, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Previous studies have shown that one in five patients who experienced their first AMI died before reaching the hospital.”
The clinical trial will evaluate the safety and effectiveness of the investigational drug selatogrel that is self-administered by a study participant when heart attack symptoms first appear. Participants in the study must have recently had a heart attack and must be considered at high risk for a recurrent heart attack.
A heart attack occurs when a blood clot blocks the flow of blood through a blood vessel that carries blood to the heart. If the clot isn’t treated quickly, the heart muscle begins to die. More than 800,000 people experience heart attacks each year in the U.S., with about 200,000 of those being recurrent. More than 100,000 people die each year from heart attacks, according to the American Heart Association.
“Selatogrel works by temporarily preventing platelets in a patient’s blood from binding and forming blood clots,” said Laura Wrona, MSN, Director of Cardiovascular Clinical Trials Research for the Research Institute. "Due to the unique profile of selatogrel, patients may have more time to get emergency medical help while preserving their heart muscle.”
Selatogrel is currently being studied as a self-administered subcutaneous injection in over 30 countries around the world, including the US.
“By enrolling participants who have recently had heart attacks and asking them to self-administer the drug when they feel symptoms of another possible heart attack, researchers are hoping to shave valuable time off the so-called ‘patient delay’ that occurs between first symptom onset and first medical intervention,” Dr. Jan said. “This delay typically lasts between two and six hours and is a critical component to address in order to improve health outcomes for patients undergoing heart attacks.”
Participants in the study will be asked to inject the drug with a ready-to-use, pre-filled study autoinjector when heart attack symptoms arise. The clinical trial is placebo-controlled, meaning some patients will randomly receive a study injector with selatogrel from their doctor and others will randomly receive a study injector filled with a harmless saltwater solution that provides no therapeutic benefit. Neither the participant nor their doctor will know which type of study autoinjector the participant received.
The sponsor of the study plans to enroll 14,000 participants at about 250 sites throughout the world.
The clinical trial, “Selatogrel outcome study in suspected acute myocardial infarction (SOS-AMI),” is sponsored by Idorsia Pharmaceuticals Ltd., manufacturer of the study drug.
To learn more about Advocate Aurora’s research, visit aah.org/research.