A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease
This clinical trial is looking at an experimental medicine called pelacarsen in adults who already have heart or blood vessel disease. Some people have high levels of a fatty substance in their blood called lipoprotein(a), or Lp(a). This is mostly inherited from parents and cannot easily be lowered with diet or common cholesterol tablets. Having high Lp(a) increases the risk of future heart problems. In this study, researchers want to see whether lowering Lp(a) with pelacarsen can protect patients against major events such as heart attacks, strokes, and emergency heart surgeries. Participants are placed into two groups at random: one group receives the active medicine, and the other receives a dummy injection (placebo). Neither the participants nor their doctors will know who is getting which treatment. The trial aims to find new ways to keep people with heart disease safe and healthy.
At a glance
What is this study about?
Cardiovascular disease is an umbrella term for conditions affecting the heart and blood circulation, such as narrowed arteries, past heart attacks, or strokes. Many people take daily medications like statins to lower standard cholesterol and protect their blood vessels. However, doctors have found that another fatty particle in the blood, called lipoprotein(a) or Lp(a), also plays a big role in heart health.
Unlike ordinary cholesterol, your Lp(a) level is largely decided by your genes. This means healthy eating, exercise, and standard statins rarely lower it by very much. People with high levels of Lp(a) face an ongoing risk of narrowed blood vessels, even if their standard cholesterol looks good. Because of this, scientists are developing new medicines specifically designed to reduce Lp(a).
This trial is testing a new injectable drug called pelacarsen (also known as TQJ230). The main goal is to find out whether lowering Lp(a) truly cuts down on serious complications, including fatal heart events, non-fatal heart attacks, strokes, and emergency bypass or stent procedures. If the results are positive, this treatment could provide an important new option for people living with cardiovascular disease.
Key takeaways
- The trial tests whether a new medicine called pelacarsen can prevent heart attacks and strokes.
- It is aimed at adults who already have cardiovascular disease and high Lp(a) blood fat levels.
- Pelacarsen is given as an injection under the skin using a pre-filled device.
- Half of the volunteers will receive the real drug and half will receive a dummy injection (placebo).
- Participation is voluntary, and you can leave the study at any time without changing your usual care.
Who may be eligible?
This trial is open to men and women aged 18 and older who already have a confirmed diagnosis of cardiovascular disease, such as a previous heart attack, stroke, or circulation problems in their arteries.
To be eligible, you must also have higher than normal levels of lipoprotein(a) in your blood. You do not need to know your levels before applying, as the study team will measure this with a blood test during your initial screening appointment.
You might not be able to join if you have other severe, uncontrolled health conditions, or if you are unable to attend regular clinic visits. The study doctor will check your full medical history and current medications to confirm if taking part is safe for you.
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.
- I am aged 18 or older.
- I have been diagnosed with heart disease, a previous heart attack, or circulation problems.
- I am willing to have a blood test to check my lipoprotein(a) levels.
- I am able to attend regular hospital appointments over several years.
- I am comfortable receiving injections under the skin.
What does participation involve?
Taking part involves visiting a hospital clinic regularly over several years. During your visits, the research team will check your overall health using routine tests, such as blood pressure checks, heart traces (ECGs), and blood tests. The study medication is given as a small injection just under the skin using a pre-filled pen or syringe. You will be assigned by chance to receive either pelacarsen or a placebo (dummy injection). The team will teach you or a carer how the injections work, monitor you closely for any changes in your health, and keep in touch between visits.
Potential risks and benefits
Locations (20)
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedPortugal
- —UnverifiedRomania
- —UnverifiedDenmark
- —UnverifiedNorway
- —UnverifiedPoland
Common questions
What is lipoprotein(a)?
Lipoprotein(a), or Lp(a), is a type of fat in your blood. High levels can cause fatty deposits to build up in your arteries, raising the risk of heart attacks and strokes.
What is a placebo?
A placebo is a dummy treatment that looks and feels exactly like the study medicine, but contains no active ingredients. It helps scientists see if the real drug works better than no treatment.
Will I have to pay for the study treatment?
No. All study medicines, clinic visits, and medical tests are provided free of charge, and travel expenses are usually reimbursed.
Can I keep taking my regular heart tablets?
Yes. This study medicine is designed to be taken alongside your usual prescribed treatments, such as blood pressure tablets or statins.
How is the medicine given?
It is given as a simple injection just under the skin, similar to how insulin is administered, using a small needle with a built-in safety device.
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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.