Study to assess the impact of Lipoprotein(a) reduction with Pelacarsen (TQJ230) on the progression of calcific aortic stenosis [Lp(a)FRONTIERS CAVS]
Summary description of the study
In this study, we aim to find out whether the study drug Pelacarsen (also known as TQJ230) can help adults diagnosed with mild or moderate calcific aortic stenosis (CAVS) and elevated Lipoprotein(a) [Lp(a)]. Approximately 502 people worldwide with CAVS who are at least 50 years old are invited to participate in this study. CAVS is a condition where the opening of the aortic valve narrows, restricting blood flow from the heart to the rest of the body, which can lead to health problems. Lipoprotein(a) [Lp(a)] is a lipid particle found in the blood and resembles LDL cholesterol (the so-called "bad cholesterol"). It is discussed that it may increase the risk of developing CAVS. The study drug Pelacarsen is not yet approved in Switzerland for the treatment of people with elevated Lp(a). To date, there is no medication that slows the progression of CAVS.
(BASEC)
Intervention under investigation
In our study, there are 2 treatment groups:
- Pelacarsen: You have a 1:1 (50 %) chance of receiving the study drug.
- Placebo: You have a 1:1 (50 %) chance of receiving the placebo, which contains no active substance.
The study drug and the placebo will be administered to you every month by subcutaneous injection (with a needle under the skin) for 3 years.
The placebo is an injection of an inactive substance and has no effect.
(BASEC)
Disease under investigation
Calcific aortic stenosis (CAVS)
(BASEC)
1. an Lp(a) ≥175 nmol/L 2. mild or moderate CAVS, defined by an echocardiographic parameter 3. participants must be optimally managed for existing cardiovascular risk factors (e.g., LDL-C, diabetes mellitus, and hypertension) (BASEC)
Exclusion criteria
1. severe CAVS, defined by echocardiographic parameters 2. planned aortic valve replacement 3. unicuspid valve or other congenital heart anomaly (BASEC)
Trial sites
Basel, Geneva, Lausanne, Lugano, Zurich
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contact
Contact Person Switzerland
Bianca Fay
+41793307663
bianca.fay@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
19.04.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS] (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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