An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with ST-Elevation Myocardial Infarction (STEMI)
A heart attack happens when blood flow to part of the heart muscle suddenly stops. In a serious type known as a STEMI, doctors carry out an emergency procedure to reopen the blocked artery. However, the heart muscle can still suffer lasting damage during and just after this event. This clinical trial is testing whether an experimental medicine called RTP-026 can reduce damage to the heart muscle and help it recover. Participants will be randomly chosen to receive either RTP-026 or a dummy treatment (a placebo) alongside their standard hospital care. Doctors will monitor participants closely using blood tests, heart tracings (ECGs), and heart MRI scans over a period of 90 days. The main goal is to check how safe the medicine is and see if it helps protect the heart better than standard care alone.
At a glance
What is this study about?
When a major artery supplying the heart becomes completely blocked, it causes a severe heart attack known as an ST-Elevation Myocardial Infarction (STEMI). In hospital, doctors act quickly to open the artery using an emergency procedure called primary percutaneous coronary intervention (PCI), which often involves placing a small mesh tube called a stent. While reopening the blood vessel saves lives, restoring blood flow can sometimes cause inflammation and further stress to the recovering heart muscle.
This research study is testing an investigational drug called RTP-026. Scientists hope that giving this medicine alongside standard emergency care will shield heart cells from further injury, reduce swelling in the heart tissue, and help the heart pump effectively in the months that follow.
To find out if the drug works, participants are randomly placed into one of two groups. One group receives RTP-026, and the other receives an inactive dummy medicine known as a placebo. Neither the patient nor the medical team will know who receives which treatment until the trial ends. This approach ensures the results are completely fair and unbiased.
Doctors will assess heart recovery by measuring specific proteins in the blood that show heart strain, and by using specialised heart MRI scans within 48 hours of treatment and again at 90 days. This allows researchers to see the exact size of any healing or scar tissue in the heart muscle.
Key takeaways
- Testing a new medicine called RTP-026 to help protect the heart after a major heart attack.
- Half of the participants receive RTP-026 and half receive a dummy medicine (placebo).
- Emergency artery-clearing treatment continues as normal without any delay.
- Involves blood tests and two heart MRI scans over a 90-day follow-up period.
- Participation is entirely voluntary and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been admitted to hospital with a confirmed, serious heart attack (STEMI) and are being treated with an emergency procedure to clear the blocked heart artery.
Because the study involves heart MRI scans and rapid treatment, it is not suitable for people who cannot safely have an MRI scan (such as those with certain non-compatible metal implants) or those with other severe medical conditions that might make participation unsafe.
Your hospital cardiology team will review your emergency scans, blood tests, and overall medical history to decide whether joining the study is safe and appropriate for your specific situation.
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.
- You are aged 18 or older
- You have had a confirmed STEMI heart attack
- You are having an emergency procedure (stent or balloon) to clear the blocked artery
- You are able to safely have an MRI scan
- You are willing to attend follow-up visits for up to 90 days
What does participation involve?
Taking part begins while you are in hospital for your emergency heart treatment. You will receive either RTP-026 or the placebo as an injection or drip alongside your usual medications. Over your first 24 hours, the nursing team will take blood samples at set times (at 6, 12, and 24 hours) to measure how your heart muscle is responding.
You will have regular heart tracings (ECGs) and blood pressure checks. Within 48 hours of your procedure, you will have a cardiac MRI scan, which takes detailed pictures of your heart muscle without using radiation. You will then be invited back for follow-up hospital visits, including a final check-up and a second heart MRI scan around 90 days (about three months) after your heart attack.
Potential risks and benefits
Locations (2)
- —UnverifiedDenmark
- —UnverifiedSweden
Common questions
Will taking part delay my emergency heart treatment?
No. Your urgent care to reopen the blocked artery is the top priority and will not be delayed by the study.
What is a placebo?
A placebo is a dummy treatment designed to look identical to the real medicine but containing no active ingredients. It helps researchers prove whether the study drug really works.
What does a cardiac MRI scan feel like?
An MRI is a safe, painless scan that uses magnets rather than radiation. It involves lying flat inside a tunnel-like scanner that makes loud tapping sounds, so you will be offered earplugs or headphones.
Can I leave the study early if I change my mind?
Yes. You can withdraw from the study at any time without giving a reason, and it will not change the quality of your regular NHS care.
Will I still receive all my standard heart attack medicines?
Yes. You will receive all standard guideline-recommended treatments, blood thinners, and recovery medicines just like any other heart attack patient.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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