A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelacarsen (TQJ230) 80mg, Matching placebo.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Canada, Czechia +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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]
Overview
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
Interventions
- Drug Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg - Drug Matching placebo
Matching placebo
Primary outcome measures
- Change in peak aortic jet velocity [Time frame: 36 months]
- Change in aortic valve calcium score [Time frame: 36 months]
Secondary outcome measures (3)
- Change in Lp(a) levels [Time frame: 12 months]
- Change in fibrocalcific thickening of the aortic valve [Time frame: 36 months]
- Time from randomization to first occurrence of composite clinical endpoint event [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- Male and female ≥50 to <80 years of age at Screening Part II
- Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- Mild or moderate calcific aortic valve stenosis
- At the randomization visit, participant must be optimally treated for existing CV risk factors
Exclusion criteria
- Severe calcific aortic valve stenosis
- Uncontrolled hypertension
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 38 centers
- Heart Center Research Llc — Huntsville
- Cardiovascular Res Found — Beverly Hills
- National Heart Institute — Beverly Hills
- Flourish Clinical Resrch Covin — Covina
- Valley Clinical Trials — Northridge
- Stanford University Medical Center — Palo Alto
- University Of California San Diego — San Diego
- UC San Francisco Medical Center — San Francisco
- … and 30 more centers
Germany · 15 centers
- Novartis Investigative Site — Frankfurt am Main
- Novartis Investigative Site — Kaiserslautern
- Novartis Investigative Site — Dresden
- Novartis Investigative Site — Leipzig
- Novartis Investigative Site — Ahaus
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — Bonn
- Novartis Investigative Site — Essen
- … and 7 more centers
Italy · 12 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 12 centers
Center list to be confirmed — check the primary protocol.
Israel · 9 centers
Center list to be confirmed — check the primary protocol.
Spain · 8 centers
Center list to be confirmed — check the primary protocol.
Canada · 7 centers
- Novartis Investigative Site — Cambridge
- Novartis Investigative Site — North York
- Novartis Investigative Site — Ottawa
- Novartis Investigative Site — Montreal
- Novartis Investigative Site — Montreal
- Novartis Investigative Site — Montreal
- Novartis Investigative Site — Québec
France · 6 centers
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Pessac
- Novartis Investigative Site — Poitiers
- Novartis Investigative Site — Rennes
Austria · 5 centers
- Novartis Investigative Site — Innsbruck
- Novartis Investigative Site — Linz
- Novartis Investigative Site — Vienna
- Novartis Investigative Site — Vienna
- Novartis Investigative Site — Vienna
Belgium · 5 centers
- Novartis Investigative Site — Genk
- Novartis Investigative Site — Yvoir
- Novartis Investigative Site — Aalst
- Novartis Investigative Site — Kortrijk
- Novartis Investigative Site — Roeselare
Czechia · 5 centers
- Novartis Investigative Site — Hradec Králové
- Novartis Investigative Site — Jaroměř
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Prague
Netherlands · 5 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 5 centers
Center list to be confirmed — check the primary protocol.
Denmark · 4 centers
- Novartis Investigative Site — Esbjerg
- Novartis Investigative Site — Hvidovre
- Novartis Investigative Site — Roskilde
- Novartis Investigative Site — Viborg
Portugal · 4 centers
Center list to be confirmed — check the primary protocol.
Publications
- Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25. PMID 39329200
Identifiers
NCT: NCT05646381 · CTQJ230A12203