A Phase 3, Randomized, Double-Blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

To join this study, you need to be an adult, aged 18 years or older. Both men and women can take part.

You would be considered for this study if you have recently had what doctors call an "Acute Coronary Syndrome." This is a general term for serious heart conditions like a heart attack (where blood flow to part of the heart is suddenly blocked) or severe unstable angina (which is chest pain caused by reduced blood flow to the heart, but without permanent heart damage).

There will also be other specific medical conditions and treatments that might mean you can or cannot join. For example, if you have certain other serious health problems or are taking particular medications, you may not be able to participate safely. A healthcare professional working on the study will carefully check all these details to see if this study is right for you.

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to receive either the new medicine, Milvexian, or a dummy pill (placebo). You will take this alongside other standard medications you might be prescribed, such as Aspirin or other anti-clotting medicines like Prasugrel, Clopidogrel, or Ticagrelor. Neither you, nor your study doctor, will know which treatment you are receiving.

Your participation will involve regular visits to the clinic for check-ups, where doctors will monitor your health, ask about any symptoms, and perform tests like blood pressure measurement and blood draws. These checks are important to see how you are responding to the medication and to keep track of your health. The total length of time you would be in the study will vary, but usually involves follow-up for a significant period to properly assess the effects of the medication.