Purpose:
Study CTQJ230A12203 is a Phase II clinical trial that aims to evaluate if treatment with pelacarsen (TQJ230) versus placebo slows the progression of mild to moderate calcific aortic valve stenosis (CAVS) and to further characterize the safety profile of this treatment. Pelacarsen has been shown in previous studies to lower lipoprotein (a) levels by nearly 90%.
Calcific aortic valve stenosis, also termed aortic valve stenosis or aortic stenosis, represents an important public health problem. With so many people suffering from aortic stenosis who may eventually need valve replacement, there is an urgent need to develop a medical treatment option to slow the progression of CAVS.
Lipoprotein (a) is well known to be associated with heart attack, stroke, and peripheral artery disease. There has also been an association of elevated lipoprotein (a) levels with degeneration of the aortic valve, or a disease referred to as aortic stenosis. The aortic valve is the main heart valve that opens during each heartbeat beat, allowing blood to flow from the heart to the arterial circulation to provide oxygen and nourishment to the body organs. Aortic stenosis is the result of a degeneration of the aortic valve caused by the formation of calcium and other unwanted substances, causing the valve to become stuck and not open as it should. During the early phase of aortic stenosis, patients may have no symptoms and only a murmur heard when using a stethoscope to listen to your heart. However, as the disease progresses and the aortic valve opening becomes smaller and smaller, symptoms include shortness of breath, fatigue, chest discomfort, dizziness, or fainting. It can be identified by the presence of a murmur when your physician listens to your heart with a stethoscope or when you undergo an ultrasound of your heart, referred to as an echocardiogram.
As aortic stenosis progresses, the valve opening becomes narrower, limiting the ability of the heart to deliver the necessary blood flow to the rest of the body. This can lead to heart failure, angina pain, and fainting. Once it has advanced this far, the aortic valve needs to be replaced surgically or by a percutaneous procedure. The purpose of this study is to determine if lowering the lipoprotein (a) level with pelacarsen will slow or stop the progression of mild to moderate aortic stenosis as observed on an echocardiogram to the more advanced stage and perhaps delay or prevent the need for aortic valve replacement.
Description:
The benefits participants may derive from participating in this study consist of closely monitoring their condition, optimizing treatment of known cardiovascular risk factors during the study, and receiving a potentially efficacious treatment for a currently unmet medical need. At the same time, the risk to participants may be minimized by rigorous compliance with the eligibility criteria and study procedures, as well as close clinical monitoring. The study has two primary goals:
1. To demonstrate the superiority of pelacarsen vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
2. To demonstrate the superiority of pelacarsen vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in aortic valve calcium score by CT scan
Key Eligibility Requirements:
(Please note: Additional eligibility requirements may be assessed at the time of study screening evaluation.)
- Male and female ≥50 to <80 years of age
- Lp(a) ≥175 nmol/L or ≥ 60 mg/dl
- Mild or moderate CAVS as defined by a peak aortic jet velocity ≥2.5 m/s and ≤3.5 m/s as measured on cardiac ultrasound or echocardiogram
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- Severe aortic stenosis defined on echocardiography by a mean gradient >40 mmHg or aortic valve <1 cm2
- Inability to undergo or to acquire an optimal echocardiogram or CT, or contraindication to CT contrast media
- Left ventricular ejection fraction <55% or suffering from symptomatic heart failure
- Severe chronic kidney disease (eGFR ≤30 mL/min/1.73 m2)
- Severe aortic stenosis defined on echocardiography by a mean gradient >40 mmHg or aortic valve <1 cm2
PARTICIPATION IN THIS TRIAL CAN BE UP TO THREE YEARS
The information we are providing includes important background on a variety of important cardiovascular conditions and ongoing clinical trials. We encourage you to use this information in discussions with your health care professional. Since enrollment in clinical trials are limited in time, we can’t guarantee their availability at any given time. However, we have continued access to new clinical trial opportunities and will share them as soon as they are available.