Study to assess the impact of Lipoprotein(a) reduction with Pelacarsen (TQJ230) on the progression of calcific aortic stenosis [Lp(a)FRONTIERS CAVS]
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
1. severe CAVS, defined by echocardiographic parameters 2. planned aortic valve replacement 3. unicuspid valve or other congenital heart anomaly (BASEC)
Lieu de l’étude
Bâle, Genève, Lausanne, Lugano, Zurich
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Bianca Fay
+41793307663
bianca.fay@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
19.04.2024
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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