Taking people in ItalyPhase 2
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Ancona, Bergamo, Brescia, Caserta, Ferrara, Milan, Padova, Pordenone, and Pozzilli, ItalySee the 11 sitesAlso in 14 other countries, 118 sites
- Trial code
- 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
- Age
- 50 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
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 Italy
Also in 14 other countries, 118 sites
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Azienda Ospedaliera Ospedale Niguarda Ca' GrandaMilan, ItalyTaking people
- Centro Cardiologico Monzino S.p.A.Milan, ItalyTaking people
- Ospedale Galeazzi S.p.A.Milan, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- Santa Maria Degli Angeli HospitalPordenone, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking 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]
- Fit questions
- Built from NCT05646381, who can take part
- Publications
- Lipids and lipoproteins in calcific aortic valve disease.Current opinion in lipidology, 2026
- Record updated
- 23 June 2026