This phase 3 trial will investigate the safety and effectiveness of CSL112 to prevent major adverse cardiac events (MACEs). The main outcome will be the time taken until the first MACE.
Acute coronary syndrome (ACS) is one type of coronary artery disease (CAD). ACS is any condition that is caused by a short-term lack of blood supply to the heart. A heart attack is an example of ACS. Patients with ACS have a high risk of another cardiac event. Heart attacks, stroke, and death due to cardiovascular (CV) failure are some of these events. In clinical practice, they are called major adverse cardiac events or MACEs. Patients with ACS are at a high risk of MACEs. CSL112 is an experimental drug to prevent MACE. It is a synthetic form of a human protein. This protein is called apolipoprotein A-I (apoA-I). ApoA-I transports cholesterol. It removes cholesterol from the plaques that block arteries in CAD.
This trial will investigate the safety and effectiveness of CSL112 to prevent MACEs. The main outcome will be the time taken until the first MACE.
Who are they looking for?
This study will recruit 17,400 patients with established CAD. Participants must have evidence of heart muscle damage following a heart attack. One of the following risk factors must be present for inclusion in the trial: a history of heart attack, diabetes, peripheral artery disease, or be aged 65 or older.
Patients cannot take part in the trial if they have a history of kidney injury or severe kidney disease. Patients with evidence of hepatobillary (liver and bile duct) disease cannot take part. Unstable blood tests and plans to undergo coronary artery bypass surgery are other excluding criteria. Patients with allergies to soy bean, peanut or albumin (a protein) cannot take part in the study.
How will it work
Patients will be randomly assigned to either a treatment or control group. Patients in the treatment group will receive CSL112. Patients in the control group will receive an inactive protein (placebo). Both groups will have an intravenous infusion of either CSL112 or placebo. Patients will be assessed after 90 days. Follow-up may last up to 1 year.
The main outcome will be the time taken until the first MACE.