Medication TQJ230 for the prevention of complications in patients with cardiovascular diseases (HORIZON)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Individuals who do not practice adequate contraception, as well as pregnant and breastfeeding women, are not eligible to participate. (BASEC)
Studienstandort
Basel, Bern, Genf, Lausanne, Zürich
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Bianca Fay
+41 79 330 76 63
bianca.fay@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Allgemeine Auskünfte
Novartis Pharmaceuticals
(ICTRP)
Wissenschaftliche Auskünfte
Novartis Pharmaceuticals
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.08.2020
(BASEC)
ICTRP Studien-ID
NCT04023552 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (ICTRP)
Untersuchte Krankheit(en)
Cardiovascular Disease and Lipoprotein(a) (ICTRP)
Untersuchte Intervention
Drug: TQJ230Drug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Novartis Pharmaceuticals, Novartis Pharmaceuticals (ICTRP)
Sekundäre IDs
CTQJ230A12301, 2019-001076-11, CTQJ230A12301 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04023552 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar