This clinical trial is focused on studying the effects of a new treatment for patients with Cardiovascular Disease. The treatment being tested is called pelacarsen, also known by its code name TQJ230. It is a solution for injection that is administered using a pre-filled syringe. The study aims to see if pelacarsen can lower levels of a specific type of fat in the blood called lipoprotein (a), which is linked to heart problems.
The purpose of the study is to determine if pelacarsen can reduce the risk of major heart-related events, such as heart attacks, strokes, and the need for urgent heart procedures, in people who already have cardiovascular disease. Participants in the study will receive either the pelacarsen treatment or a placebo. The study will monitor participants over a period to see how the treatment affects their health and the occurrence of these major events.
Throughout the study, participants will receive regular injections and will be closely monitored by healthcare professionals. The study will help researchers understand if lowering lipoprotein (a) with pelacarsen can provide significant benefits for people with cardiovascular disease. The results could lead to new treatment options for managing heart health in the future.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a lipoprotein (a) level of at least 70 mg/dL and a history of cardiovascular disease.
The study involves patients who have had a heart attack or stroke at least three months prior to joining, or who have significant peripheral artery disease.
2randomization
Participants are randomly assigned to receive either the active medication, pelacarsen (TQJ230), or a placebo.
The study is double-blind, meaning neither the participants nor the researchers know who receives the active medication or the placebo.
3medication administration
The medication, pelacarsen or placebo, is administered as a solution for injection using a pre-filled syringe with a needle safety device.
The injection is given under the skin, a method known as subcutaneous use.
4monitoring and follow-up
Participants are monitored for the occurrence of major cardiovascular events, such as cardiovascular death, non-fatal heart attack, non-fatal stroke, and urgent coronary revascularization requiring hospitalization.
Regular follow-up visits are scheduled to assess the health status and any changes in lipoprotein (a) levels.
5study duration
The study is expected to continue until July 2025.
Participants will be involved in the study for the entire duration, with regular assessments and monitoring throughout.
Who Can Join the Study?
Must have a blood level of Lp(a) (a type of fat in the blood) that is equal to or greater than 70 mg/dL at the screening visit.
Must be receiving the best possible treatment to lower LDL-cholesterol (a type of bad cholesterol).
If you have had a myocardial infarction (heart attack), it must have occurred at least 3 months ago but not more than 10 years before the screening visit.
If you have had an ischemic stroke (a type of stroke caused by a blockage in the blood supply to the brain), it must have occurred at least 3 months ago but not more than 10 years before the screening visit.
Must have clinically significant symptomatic peripheral artery disease, which means having symptoms due to narrowed blood vessels in the legs.
Both men and women can participate.
Participants can be from a vulnerable population, meaning they may have additional health or social challenges.
Who Cannot Join the Study?
Patients with certain types of cardiovascular disease may not be eligible. Cardiovascular disease refers to conditions affecting the heart and blood vessels.
Individuals with a lipoprotein(a) level less than 70 mg/dL may not be eligible. Lipoprotein(a) is a type of fat in the blood that can affect heart health.
Participants who are not within the specified age range may be excluded. The study includes certain age groups only.
Both males and females are eligible, but certain conditions may apply to each gender.
Individuals considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection or care.
Pelacarsen (TQJ230) is a medication being studied for its ability to lower lipoprotein (a) levels in the blood. Lipoprotein (a) is a type of fat that can contribute to the development of cardiovascular diseases. The trial is investigating whether reducing lipoprotein (a) with pelacarsen can decrease the risk of major cardiovascular events, such as heart attacks, strokes, and the need for urgent heart procedures, in patients who already have cardiovascular disease.
Cardiovascular Disease – This is a group of disorders affecting the heart and blood vessels. It often involves narrowed or blocked blood vessels, which can lead to chest pain, heart attacks, or strokes. Over time, these conditions can cause the heart to weaken or fail. The disease progresses as plaque builds up in the arteries, leading to reduced blood flow. This can result in various complications, including heart rhythm problems and heart valve issues. Lifestyle factors such as diet, exercise, and smoking can influence the progression of cardiovascular disease.
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