Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting

This important study, called a Phase 3 trial, is looking at a new medicine named zalunfiban. It's for people who are experiencing a very serious type of heart attack called STEMI, where a major artery supplying the heart is completely blocked. The main goal is to find out if giving a single injection of zalunfiban very early, before arriving at the hospital for usual treatment, can improve how well people recover and if it's safe. Some participants will receive zalunfiban, while others will get a placebo (a dummy injection) to fairly compare its effects. Researchers will track different health outcomes and any side effects over time to understand if zalunfiban could be a helpful new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Celecor Therapeutics Inc.

Enrolment target

2,507

Start

19 Dec 2023

Subjects with documented STEMI presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads in whom the total duration of symptoms to diagnostic ECG is anticipated to be within 4 hours.

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final stages of testing a new medicine before it might become widely available. The medicine being tested is called zalunfiban, and it's for people who are having a very serious heart attack, known as a STEMI. In a STEMI, one of the main arteries that carries blood to your heart becomes completely blocked. This blockage means your heart muscle isn't getting enough oxygen, which can cause significant damage.

The idea behind this study is to see if giving zalunfiban as a single injection very early, even before you get to the hospital for procedures like angioplasty (where doctors unblock the artery), can make a positive difference. The researchers want to know if it can help reduce the damage to the heart, prevent further problems like another heart attack or stroke, and improve overall recovery. They are also looking very carefully at the safety of the drug.

To make sure the results are fair and accurate, some participants will receive the actual drug, zalunfiban, while others will receive a placebo. A placebo looks just like the real drug but contains no active medicine. This allows doctors to compare the effects of zalunfiban against what would happen without it. Everyone involved, including the patients and the medical staff treating them, won't know whether they're getting the active drug or the placebo. This helps prevent any bias in the study results and ensures that the medicine's true effects can be understood.

Key takeaways

This study is for people having a very serious type of heart attack (STEMI).
It tests a new drug, zalunfiban, given as an early injection.
The goal is to see if zalunfiban improves recovery and is safe.
Participants will receive either zalunfiban or a placebo (dummy drug).
Results for important health outcomes will be checked for 30 days, with some safety follow-ups for up to a year.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older.

You would also need to be experiencing a specific type of severe heart attack called a STEMI. This means you would have ongoing chest pain that has lasted for more than 10 minutes and specific changes on your heart tracing (ECG) that doctors look for. Additionally, it would be expected that you could receive your initial ECG and be assessed for the study within four hours of your symptoms starting.

It's important to remember that these are just some of the main requirements. A doctor or healthcare professional involved in the study would need to review all your specific medical details to confirm if you meet all the necessary criteria to take part.

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.

Are you 18 years old or older?
Are you currently having chest pain that has lasted longer than 10 minutes?
Do your doctors suspect you are having a STEMI (a severe heart attack)?
Is it expected that an ECG and study assessment can happen within 4 hours of your symptoms starting?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you would receive a single injection of either zalunfiban or a placebo. This would happen very soon after your heart attack symptoms begin and before you receive more involved treatments at the hospital. Doctors and study staff will carefully monitor you during your hospital stay and for a period after.

Throughout the study, you would have several check-ups and assessments. These would involve doctors looking at your heart's condition, measuring certain things in your blood, and asking about your symptoms and how you're feeling. They will also carefully record any side effects you might experience. The main part of tracking your health outcomes will happen within 30 days of the injection, but some safety information, such as serious side effects, hospital stays, and heart rhythm issues, will be collected for up to 12 months. The research team will explain all the visits and tests in detail.

Potential risks and benefits

Taking part in this study means you could potentially benefit from receiving a new treatment that might improve outcomes after a heart attack. However, as with any new medicine, there are potential risks, and zalunfiban could have side effects, including bleeding, which the study will monitor very closely. You will be monitored carefully throughout. Participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Romania
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Unverified
Czechia
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Unverified
France
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Unverified
Hungary

Common questions

What is a STEMI?

STEMI stands for ST-elevation myocardial infarction. It's a very serious type of heart attack where a main artery supplying blood to your heart is completely blocked.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the actual study drug but doesn't contain any active medicine. It helps researchers compare the effects of the new drug fairly.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your doctors will know if you're receiving zalunfiban or the placebo. This is called 'blinding' and helps ensure the study results are unbiased.

How long will I be involved in the study?

The main part of monitoring your health outcomes will be for 30 days. However, some safety information, like serious side effects, will be checked for up to 12 months.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.