A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

To be considered for this study, you would typically be an adult (18 years or older) and weighing between 52 and 130 kilograms. You must be experiencing a specific type of severe heart attack called a STEMI, with chest pain that has lasted more than 10 minutes but started no more than 4 hours ago. For women, if you are under 50, you would need to be past menopause or have had surgery that prevents you from having children.

There are also reasons why you might not be able to join. For example, if you've recently had a serious bleed, major surgery, or a stroke. You also wouldn't be able to participate if you're currently taking strong blood-thinning medications, are on kidney dialysis, or have certain very low blood pressure or high heart rate readings. The study cannot include those who have tested positive for COVID-19 or have other serious health conditions that might make participation unsafe.

If you meet the initial criteria, ambulance staff will ask for your agreement to take part very quickly. You’ll then receive a single injection under the skin in the ambulance – this will be either zalunfiban or a placebo. After the injection, you’ll be taken to a hospital heart centre for immediate angiography and treatment to clear the heart blockage.

Throughout your hospital stay, doctors and nurses will monitor your health closely, record all your medications, and collect blood samples at specific times (like 1, 6, 24, and 72 hours after initial treatment). They will also look for any side effects, particularly bleeding or skin reactions where you had the injection. Your heart scans and electrical readings will be carefully reviewed. After leaving the hospital, you’ll have phone calls to check on your health: one around 30 days later, and another after a year to see how you are doing long-term.