Pelacarsen for calcific aortic valve stenosis, compared with placebo
Tests pelacarsen against placebo for slowing calcific aortic valve stenosis.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Braga, Cascais, Coimbra, and Vila Nova de Gaia, PortugalSee the 4 sitesAlso in 14 other countries, 125 sites
- Trial code
- Registry title
- A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 502 people, planned
- Started
- 7 Mar 2024
- Expected to end
- 12 Mar 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Pelacarsen (TQJ230) 80mg
- Matching placebo
- Record updated
- 23 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild or moderate calcific aortic valve stenosis (a stiff, narrowed heart valve) and high Lp(a). It tests pelacarsen (TQJ230) against placebo.
- Age
- 50 to under 80 years at screening
- Sex
- Men and women
- Disease stage
- Mild or moderate calcific aortic valve stenosis. Severe stenosis cannot join.
- Earlier treatment
- At randomization, existing heart and blood vessel risk factors must be fully treated.
- Biomarker or test result
- Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
Main reasons for not taking part
- Severe calcific aortic valve stenosis or uncontrolled high blood pressure
- Any past cancer
- Past bleeding stroke or other major bleeding
- Platelet count at or below the lower normal limit
- Active liver disease, poor liver function, significant kidney disease, or pregnant or breastfeeding
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Uncontrolled hypertension
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Platelet count ≤ LLN
- Severe calcific aortic valve stenosis
- Pregnant or nursing women; Other protocol-defined inclusion/exclusion criteria may apply
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 80 years old?
Where in Portugal
Also in 14 other countries, 125 sites
- CCAB Centro Clinico Academico Braga AssociacaoBraga, PortugalTaking people
- Galo Saude Parcerias Cascais S.A.Cascais, PortugalTaking people
- Centro Hospitalar E Universitărio de Coimbra E.P.E.Coimbra, PortugalTaking people
- Unidade Local de Saúde de Gaia/Espinho, E. P. EVila Nova de Gaia, PortugalTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Pelacarsen (TQJ230) 80mgTreatment being tested
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
- Matching placeboPlacebo, for comparison
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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]
- Plain-language title
- Pelacarsen for calcific aortic valve stenosis, compared with placeboGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT05646381, who can take part
- Publications
- Lipids and lipoproteins in calcific aortic valve disease.Current opinion in lipidology, 2026
- Oral agents for lowering lipoprotein(a).Current opinion in lipidology, 2024
- Record updated
- 23 June 2026