Last Update: Aug 09, 2024
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]
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTQJ230A12203
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Aortic Stenosis
Phase2
Recruiting
502
Mar 07, 2024
Jan 03, 2029
All
50 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

Matching placebo

Matching placebo
Drug

Pelacarsen (TQJ230) 80mg

Pelacarsen (TQJ230) 80mg

Eligibility Criteria

Inclusion Criteria:

- Male and female ≥50 to <80 years of age

- 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

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals