Active not recruitingPHASE3INTERVENTIONAL

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

This research study is testing a new medicine called Pelacarsen (also known as TQJ230). The main goal is to find out if Pelacarsen can help lower the risk of serious heart problems, like heart attacks or strokes, in people who already have heart disease and high levels of a particular type of cholesterol called Lipoprotein(a) (Lp(a)). High Lp(a) levels can increase the risk of heart and blood vessel issues. During this study, some participants will receive the new medicine, while others will get a dummy treatment (placebo) to fairly compare its effects. This is a large, important study in its final stages of testing before a medicine might be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

8,323

Start

12 Dec 2019

Estimated completion

30 Jun 2026

Cardiovascular Disease and Lipoprotein(a)

What is this study about?

Heart and blood vessel diseases are very common and can lead to serious health problems like heart attacks and strokes. In this study, we're focusing on people who have already experienced these kinds of issues. We know that different types of cholesterol can affect your heart health. One specific type, called Lipoprotein(a) or Lp(a), is inherited and, when high, can increase your risk of future heart problems, even if other cholesterol levels are well managed.

This research is looking at a new medicine called Pelacarsen. The idea is that Pelacarsen might be able to lower the levels of Lp(a) in your blood. By doing this, the researchers hope to reduce your chances of having another serious heart event. This study is a 'Phase 3' trial, which means it's one of the final and most important stages of testing for a new medicine. It involves a large number of people to make sure the results are clear and reliable.

Taking part in a study like this helps us understand new treatments better. If Pelacarsen is shown to be safe and effective, it could offer a new way to protect people with heart disease and high Lp(a) from future complications, giving them a better quality of life.

Key takeaways

Tests a new medicine (Pelacarsen) for heart disease.
Aims to lower a specific type of cholesterol called Lipoprotein(a) (Lp(a)).
For people who have already had a heart attack or stroke.
Involves receiving either the new medicine or a dummy treatment.
Requires regular clinic visits and health check-ups.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have heart disease and blood tests showing you have high levels of a specific type of cholesterol called Lipoprotein(a) (Lp(a)). Your heart disease could be a previous heart attack or stroke that happened between 3 months and 10 years ago, or a condition affecting the blood vessels in your legs.

There are also some reasons why you wouldn't be able to join. For example, if you have very high blood pressure that isn't under control, severe heart failure, certain types of cancer, a history of bleeding in the brain, or significant problems with your liver or kidneys. Also, women who are pregnant or breastfeeding cannot take part.

Your study doctor will go through all the requirements in detail to make sure this study is the right fit for you. There might be other specific health conditions or medications that would prevent you from taking part, but these will be discussed openly during your screening appointments.

Quick self-check

Are you between 18 and 80 years old?
Have you had a heart attack or stroke (not in the last 3 months)?
Have you been told you have high Lipoprotein(a) (Lp(a))?
Do you have well-controlled blood pressure?
Are you NOT pregnant or breastfeeding?
Do not have severe kidney or liver disease?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new medicine, Pelacarsen, or a dummy medicine (placebo). You won't know which one you're getting, nor will your study doctor, to ensure the results are fair. This medicine will likely be given by injection. You'll have regular visits to the clinic for medical check-ups, blood tests, and to make sure you're feeling well and the treatment isn't causing any unexpected problems.

These visits will involve monitoring your health closely. The exact number of visits and the full duration of the study can vary, but studies like this often last for a few years. You'll have medical assessments, and regular blood tests to check your Lp(a) levels and other markers of your health. All study related medical care and medication will be provided by the study team. You'll be given a schedule for all appointments and treatments if you join.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge and possibly helping others in the future. You'll also receive careful medical monitoring throughout the study. However, there are potential risks, including side effects from the study medication, which may be unknown or different from those experienced with standard treatments. There's also no guarantee that the study medicine will improve your condition. All potential risks and side effects will be fully explained before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (904)

SEC Clinical Research LLC
Andalusia, United States
Grandview Med Group Research LLC
Birmingham, United States
Novartis Investigative Site
Birmingham, United States
Heart Center Research Llc
Huntsville, United States
Novartis Investigative Site
Huntsville, United States
Mobile Heart Specialists
Mobile, United States
Novartis Investigative Site
Mobile, United States
Novartis Investigative Site
Cottonwood, United States
Mercy Gilbert Medical Center
Gilbert, United States
Clinical Research Inst of Arizona
Sun City West, United States
Novartis Investigative Site
Sun City West, United States
Eclipse Clinical Research
Tucson, United States

+892 more sites — see the official record for the full list.

Common questions

What is Lipoprotein(a) (Lp(a))?

Lp(a) is a type of 'bad' cholesterol that circulates in your blood. High levels can increase your risk of heart problems.

What is Pelacarsen (TQJ230)?

Pelacarsen is a new experimental medicine being tested to see if it can lower high levels of Lipoprotein(a) in the blood.

Will I definitely get the new medicine?

No, you might receive the new medicine or a dummy treatment (placebo). It's randomly assigned, and neither you nor your doctor will know which you are getting.

How long will the study last?

Clinical trials of this type can last for several years, involving regular clinic visits and follow-up tests.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your regular medical care.