This clinical trial is focused on studying the effects of a new treatment for patients who have experienced a recent heart attack, also known as Acute Coronary Syndrome. The treatment being tested is called milvexian, which is an oral medication designed to help reduce the risk of further heart-related events. The study will compare milvexian to a placebo, alongside standard treatments that patients are already receiving. Other medications involved in the study include prasugrel, acetylsalicylic acid (commonly known as aspirin), ticagrelor, and clopidogrel.
The purpose of the study is to determine if milvexian can effectively lower the risk of major adverse cardiovascular events, such as heart attacks, strokes, or cardiovascular-related deaths, when added to the usual care. Participants in the study will be randomly assigned to receive either milvexian or a placebo, and they will continue their regular heart medications. The study will last for a period of up to 48 weeks, during which participants will take the study medication orally in the form of film-coated tablets.
Throughout the study, participants will be monitored for any heart-related events and overall health. The goal is to see if milvexian can provide additional protection against serious heart problems compared to the placebo. This research aims to improve the understanding of how to better prevent recurrent cardiovascular events in patients who have recently suffered from a heart attack.
1joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication, milvexian, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.
2medication administration
Participants will take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol and communicated to the participant by the study team.
3regular check-ups
Participants will attend regular check-ups to monitor their health and the effects of the medication. These check-ups will include assessments of heart health and any potential side effects.
4reporting symptoms
Participants are required to report any new symptoms or changes in their health to the study team promptly. This helps ensure participant safety and the accuracy of study results.
5completion of the study
The study is expected to continue until November 2026. Participants will be informed about the end of their participation and any follow-up procedures that may be necessary.
Who Can Join the Study?
Participants must have had a recent heart problem called Acute Coronary Syndrome (ACS) within the last 7 days. This includes:
A heart issue that happened suddenly and was not planned.
A diagnosis of ACS, which can be a heart attack with or without certain changes on an ECG, or a condition called unstable angina.
Increased levels of certain heart-related substances in the blood, like troponin or creatine kinase-MB (CK-MB), which are checked by a lab test.
Participants must have at least 2 of the following risk factors:
Be 65 years old or older.
Have diabetes mellitus, a condition where blood sugar levels are too high.
Have had a heart attack before the recent ACS event.
Have a condition called multivessel coronary artery disease, which means more than one artery in the heart is affected.
Have had heart surgery called coronary artery bypass graft (CABG) before the recent ACS event.
Have a history of peripheral artery disease (PAD) or other blood vessel diseases, like issues with the carotid artery or arteries in the brain.
Have been treated without surgery or stents after the recent ACS event.
Have certain high-risk features in the heart’s arteries, such as:
A stent longer than 30 millimeters.
A blood clot in the target area.
A complex area treated with more than one stent.
A hardened area treated with a special procedure called atherectomy.
Treatment of a major artery in the heart during the recent ACS event.
All female participants who can have children must have a negative pregnancy test before starting the study.
Female participants must not be pregnant, breastfeeding, or planning to become pregnant until 4 days after the last dose of the study medication.
Who Cannot Join the Study?
Patients who have had a recent heart attack or stroke.
Patients with a history of bleeding disorders. This means conditions where the blood does not clot properly.
Patients currently taking other blood thinners. These are medications that prevent blood clots.
Patients with severe liver disease. The liver is an organ that helps process medications and remove toxins from the body.
Patients with severe kidney disease. The kidneys help filter waste from the blood.
Patients who are pregnant or breastfeeding.
Patients with a known allergy to the study medication or similar drugs.
Patients who have participated in another clinical trial within the last 30 days.
Milvexian is a medication being tested in this clinical trial. It is taken by mouth and works by blocking a specific protein in the blood called Factor XIa. This protein is involved in the process that causes blood clots to form. By inhibiting this protein, Milvexian aims to reduce the risk of serious heart-related events such as heart attacks, strokes, and cardiovascular death, especially in people who have recently experienced a severe heart problem known as acute coronary syndrome. The goal of the trial is to see if Milvexian, when added to the usual care, is more effective than not using it at all.
Acute Coronary Syndrome – Acute Coronary Syndrome (ACS) is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This condition can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. ACS can progress to more severe heart conditions, such as a heart attack, if the blood flow is not restored quickly. The symptoms may also include pain in the arms, neck, jaw, shoulder, or back, along with nausea, shortness of breath, or lightheadedness. The progression of ACS requires immediate medical attention to prevent further complications.
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