Medication TQJ230 for the prevention of complications in patients with cardiovascular diseases (HORIZON)
Résumé de l'étude
The aim of this study is to investigate whether the investigational drug named TQJ230 can reduce the risk of cardiovascular disease in patients with elevated lipoprotein(a), abbreviated as Lp(a), compared to placebo.
(BASEC)
Intervention étudiée
This study investigates whether the drug named TQJ230 is safe and can help patients with existing cardiovascular disease and elevated lipoprotein(a) to reduce the risk of heart attack, stroke, procedures to restore blood flow in the coronary arteries, or death. The investigational drug TQJ230 reduces the formation of a protein that is a component of Lp(a). This subsequently lowers the level of Lp(a) in the blood. TQJ230 is administered subcutaneously.
(BASEC)
Maladie en cours d'investigation
In cardiovascular disease, blood vessels can become blocked, which can lead to a heart attack or stroke, or to circulation problems in other vessels, e.g., in the legs. Lipoprotein(a), abbreviated as Lp(a), is a particle found in the blood that carries blood fats. When too much of it is present, it can increase the likelihood of developing cardiovascular disease. Patients who have already had a heart attack or stroke or peripheral artery disease and have elevated Lp(a) have an increased risk of further cardiovascular complications.
(BASEC)
Eligible to participate are patients who are at least 18 years old, suffering from an existing cardiovascular disease and having elevated lipoprotein(a) levels. A pre-existing cardiovascular disease is defined as a history of heart attack, stroke, or peripheral artery disease. (BASEC)
Critères d'exclusion
Individuals who do not practice adequate contraception, as well as pregnant and breastfeeding women, are not eligible to participate. (BASEC)
Lieu de l’étude
Bâle, Berne, Genève, Lausanne, Zurich
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Bianca Fay
+41 79 330 76 63
bianca.fay@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Informations générales
Novartis Pharmaceuticals
(ICTRP)
Informations scientifiques
Novartis Pharmaceuticals
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
05.08.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04023552 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with TQJ230 on major cardiovascular events in patients with established cardiovascular disease (BASEC)
Titre académique
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease (ICTRP)
Titre public
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (ICTRP)
Maladie en cours d'investigation
Cardiovascular Disease and Lipoprotein(a) (ICTRP)
Intervention étudiée
Drug: TQJ230Drug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Key Inclusion Criteria
- Lp(a) = 70 mg/dL at the screening visit, measured at the Central laboratory
- Myocardial infarction: = 3 months from screening and randomization to = 10 years
prior to the screening visit
- Ischemic stroke: = 3 months from screening and randomization to = 10 years prior to
the screening visit
- Clinically significant symptomatic peripheral artery disease
Key Exclusion Criteria
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count =LLN
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply at the end. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) = 70 mg/dL;Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) = 90 mg/dL. (ICTRP)
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke);Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization;Time to Clinical endpoint Committee confirmed all-cause death;Change in Lp(a) in the log scale from baseline (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Novartis Pharmaceuticals, Novartis Pharmaceuticals (ICTRP)
ID secondaires
CTQJ230A12301, 2019-001076-11, CTQJ230A12301 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04023552 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible