This clinical trial is focused on studying acute myocardial infarction, commonly known as a heart attack. The study is evaluating a treatment called Selatogrel, which is a solution for injection that participants can administer themselves using a pre-filled injector. The purpose of the study is to assess how effective and safe Selatogrel is when used to prevent death from any cause and to treat heart attacks in people who have recently experienced one.
Participants in the study will be randomly assigned to receive either Selatogrel or a Selatogrel matching placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will follow participants over a period to observe the occurrence of death or another heart attack after they have self-administered the treatment.
The study will also monitor for any safety concerns, such as bleeding events, that may occur within two days after taking the treatment. Additionally, researchers will look at other outcomes like hospital visits for heart failure within 30 days after treatment. This trial aims to provide valuable information on the potential benefits and risks of using Selatogrel for individuals at risk of having another heart attack.
1joining the study
Upon joining the study, the participant must have signed and dated the informed consent form. This confirms understanding and agreement to participate in the study.
The participant must be at least 18 years old and have a confirmed diagnosis of a recent acute myocardial infarction (AMI), either STEMI or NSTEMI, within the last four weeks.
2eligibility confirmation
Eligibility is confirmed by the presence of multivessel coronary artery disease, defined as 50% or more stenosis in two or more coronary artery territories or the left main artery.
Additional risk factors such as a second prior AMI, diabetes, chronic kidney disease, peripheral artery disease, or unsuccessful coronary revascularization are considered.
3self-administration training
Participants must successfully self-administer a placebo using an autoinjector during the screening phase. This ensures familiarity with the device and procedure.
4treatment phase
During the treatment phase, participants will self-administer selatogrel or a matching placebo subcutaneously. This is done upon experiencing symptoms suggestive of an AMI.
The medication is provided in a solution for injection in a pre-filled injector.
5monitoring and follow-up
Participants are monitored for the occurrence of death or non-fatal AMI after any self-administration of the study treatment. The severity of outcomes is ranked, with death being the most severe.
Safety is assessed by monitoring for treatment-emergent bleeding events within two days after administration.
6secondary outcomes
Secondary outcomes include the occurrence of death, non-fatal AMI, hospitalization, or unplanned emergency department visits for heart failure within 30 days after any treatment administration.
Who Can Join the Study?
Sign and date an informed consent form before any study-related procedures. This means you agree to participate and understand what the study involves.
Be a male or female who is at least 18 years old when signing the consent form.
Have a confirmed diagnosis of a Type 1 acute myocardial infarction. This is a type of heart attack. It should be either a ST-elevation myocardial infarction (STEMI) or a Non-ST-elevation myocardial infarction (NSTEMI), and it must have occurred no more than 4 weeks before joining the study.
Have multivessel coronary artery disease. This means there is a narrowing of 50% or more in two or more areas of the heart’s blood vessels, or in the main artery of the heart. This should have been found during a heart test called cardiac catheterization. You also need to have at least two of the following risk factors:
Had a second heart attack before.
Have diabetes mellitus, which is a condition where your body has trouble controlling blood sugar, and you are receiving treatment for it.
Have chronic kidney disease, meaning your kidneys are not working well, with a specific measure called estimated glomerular filtration rate being less than 60.
Have peripheral artery disease, which is a condition affecting blood flow in the limbs, at any time before joining the study.
Have not had, or had unsuccessful, heart vessel repair for the heart attack that qualifies you for the study.
Successfully use a placebo, which is a harmless substance, with an autoinjector device during the screening process. This shows you can use the device correctly.
Who Cannot Join the Study?
Individuals who have had a recent acute myocardial infarction (AMI), which is a heart attack.
People who are not able to self-administer the study medication when they experience symptoms that might suggest a heart attack.
Participants who are not at risk of having another heart attack.
Individuals who are not within the specified age range for the study.
People who are not part of the specified clinical trial groups.
Participants who are not male or female, as the study includes both genders.
Individuals who are considered part of a vulnerable population, which means they might need special protection or care.
Selatogrel is a medication being studied for its ability to prevent death and treat heart attacks in people who have recently experienced a heart attack. It is designed to be self-administered by the patient when they notice symptoms that might indicate another heart attack. The goal is to see if this medication can effectively reduce the risk of having another heart attack and improve survival rates.
Acute Myocardial Infarction (AMI) – This condition, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. The blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. During an AMI, the affected heart muscle loses its blood supply and can become permanently damaged if not treated promptly. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The severity and progression of the condition can vary, with some individuals experiencing mild symptoms and others having more severe complications.
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