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Enrolling by invitationPHASE3INTERVENTIONAL

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

This study is called the Selatogrel Outcome Study and focuses on people who have recently been in hospital because of a heart attack. If you’ve had a certain type of heart attack and also have other health risks, you might be eligible. The main goal is to see if a new medicine, Selatogrel, can help prevent another heart attack. Participants would learn how to give themselves the medicine, using an auto-injector, right when they feel symptoms of a heart attack starting. Researchers want to compare Selatogrel to a dummy medicine (placebo) to understand how well it works and if it's safe.

At a glance

Status
Enrolling by invitation
Phase
PHASE3
Sponsor
Viatris Innovation GmbH
Enrolment target
25,000
Start
14 Aug 2021
Estimated completion
01 Dec 2026

What is this study about?

Imagine you've recently experienced a heart attack, and doctors want to find ways to protect you from having another. This study, called the Selatogrel Outcome Study, is designed to investigate a new medication called Selatogrel. It's for people who have recently been discharged from the hospital after a specific type of heart attack and who have other risk factors that make them more likely to have another one.

The main idea is to see if Selatogrel can be used as an emergency treatment. If you were part of this study and started feeling symptoms that might suggest another heart attack, you would take your assigned medicine (either Selatogrel or a dummy medicine called a placebo) using a special auto-injector. This study aims to find out if taking Selatogrel this way can effectively reduce the risk of a repeat heart attack.

This research is important because it could lead to a new way for people at high risk to quickly respond to potential heart attack symptoms, potentially improving outcomes and saving lives. By carefully comparing Selatogrel to a placebo, the researchers can determine if it's a safe and effective option.

Key takeaways

  • This study is testing a new emergency treatment, Selatogrel, for people at risk of a second heart attack.
  • It involves using an auto-injector to give yourself the medicine if you feel heart attack symptoms.
  • Participation is for adults who have recently had a specific type of heart attack and have other health risks.
  • You might receive the active drug or a dummy medicine (placebo).
  • There's a potential benefit of reducing future heart attack risk, but also risks like bleeding.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women, who have recently had a heart attack and meet certain health requirements. Specifically, you would need to have had a confirmed heart attack of a certain type (called Type 1) within the last four weeks. You also need to have other health conditions, such as narrowed blood vessels in your heart, along with at least one additional risk factor like a previous heart attack, diabetes, kidney problems, or circulation issues in your legs.

There are also some reasons why you might not be able to join. For example, if you have a high risk of serious bleeding, have had certain types of strokes recently, have very low levels of certain blood cells, or have serious liver problems, this study might not be right for you. Your doctor would carefully review your full medical history to determine if you are a good fit.

Before you start, you'd also need to be able to successfully practice using the auto-injector with a dummy medicine, to make sure you can administer the treatment correctly if needed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you had a heart attack in the last four weeks?
  2. Do you have narrowed blood vessels in your heart diagnosed by a doctor?
  3. Do you have at least one of these: a previous heart attack, diabetes under treatment, kidney problems, or circulation issues in your legs?
  4. Do you feel confident you could use an auto-injector if needed?
  5. Do you have any serious bleeding problems or recent strokes?
  6. Are you currently on three different blood-thinning medications?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either Selatogrel or a placebo (a dummy medicine with no active ingredients). You would be provided with an auto-injector and trained on how to use it. The idea is that if you experience symptoms that suggest another heart attack, you would give yourself the assigned medicine following the instructions. You would have regular check-ups with the study team to monitor your health and any events that occur. The exact number of visits and the total duration aren't specified here, but clinical trials usually involve ongoing follow-up for a significant period to track long-term effects. You would continue to see your usual doctors as well.

Potential risks and benefits

Taking part in this study could potentially offer an early intervention with a new medication, which might help reduce your risk of a future heart attack. However, as with any medical study, there are potential risks. Selatogrel affects blood clotting, so there's a possibility of increased bleeding, and the study screens carefully for this. You might also experience side effects from the medication. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (786)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Advanced Cardiovascular, LLC
    Verified postcode
    Alexander City, United States
  • Birmingham VA Health Care System
    Verified postcode
    Birmingham, United States
  • Cardiovascular Associates of the Southeast
    Verified postcode
    Birmingham, United States
  • Grandview Medical Center and Affinity Cardiovascular Specialists, LCC
    Verified postcode
    Birmingham, United States
  • Heart Center Research, LLC
    Verified postcode
    Huntsville, United States
  • Dignity Health Mercy Gilbert Medical Center
    Verified postcode
    Gilbert, United States
  • Mayo Clinic Arizona
    Verified postcode
    Phoenix, United States
  • University of Arizona - Sarver Heart Center
    Verified postcode
    Tucson, United States
  • Amicis Research Center.
    Verified postcode
    Anaheim, United States
  • John Muir Health
    Verified postcode
    Concord, United States
  • Profound Research LLC at San Diego Cardiovascular Associates
    Verified postcode
    La Jolla, United States
  • San Francisco VA Health Care System"
    Verified postcode
    San Francisco, United States

Common questions

What is a placebo?

A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine to not taking the active drug.

What if I get symptoms but am not sure if it's a heart attack?

The study team will give you clear instructions on when to use the auto-injector. You should always follow professional medical advice if you suspect a serious health issue.

Will I know if I'm getting Selatogrel or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving. This helps make the study results as accurate as possible.

What happens if I need to take other medications during the study?

You will discuss all your medications with the study team. Some medicines might not be compatible with the study drug, and you'll be given guidance on this.

How long will I be in the study?

The information provided doesn't state the exact length, but typically these types of studies involve follow-up over several months or even years. You can ask the study team for more details.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Selatogrel Outcome Study in Suspected Acute Myocardial Infar…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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