Medication TQJ230 for the prevention of complications in patients with cardiovascular diseases (HORIZON)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Individuals who do not practice adequate contraception, as well as pregnant and breastfeeding women, are not eligible to participate. (BASEC)
Luogo dello studio
Basilea, Berna, Ginevra, Losanna, Zurigo
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Bianca Fay
+41 79 330 76 63
bianca.fay@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Informazioni generali
Novartis Pharmaceuticals
(ICTRP)
Informazioni scientifiche
Novartis Pharmaceuticals
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
05.08.2020
(BASEC)
ID di studio ICTRP
NCT04023552 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (ICTRP)
Malattie studiate
Cardiovascular Disease and Lipoprotein(a) (ICTRP)
Intervento studiato
Drug: TQJ230Drug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Novartis Pharmaceuticals, Novartis Pharmaceuticals (ICTRP)
ID secondari
CTQJ230A12301, 2019-001076-11, CTQJ230A12301 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04023552 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile