A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

a study on Aortic Stenosis

Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Anna Narezkina (ucsd)Eveline Stock (ucsf)
Headshot of Eveline Stock
Eveline Stock

Description

Summary

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.

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]

Keywords

Aortic Stenosis, Cardiovascular, Lipoprotein(a), Lp(a), Hyperlipoproteinemia(a), Calcific aortic valve stenosis, TQJ230, Pelacarsen, Aortic valve stenosis, Counterfeit Drugs, Pelacarsen (TQJ230) 80mg

Eligibility

You can join if…

Open to people ages 50-80

  • 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

You CAN'T join if...

  • 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

Locations

  • University Of California San Diego accepting new patients
    San Diego 5391811 California 5332921 92103-8415 United States
  • UC San Francisco Medical Center accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • Cardiovascular Res Found accepting new patients
    Beverly Hills 5328041 California 5332921 90210 United States
  • National Heart Institute accepting new patients
    Beverly Hills 5328041 California 5332921 90211 United States
  • Valley Clinical Trials accepting new patients
    Northridge 5377985 California 5332921 91325 United States
  • Stanford University Medical Center accepting new patients
    Stanford 5398563 California 5332921 94305 United States
  • Foothill Cardiology accepting new patients
    Covina 5340175 California 5332921 91723 United States

Lead Scientists at University of California Health

  • Anna Narezkina (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 9 research publications
  • Eveline Stock (ucsf)
    Dr. Eveline Oestreicher Stock is a cardiologist specializing in general cardiology and cholesterol metabolism disorders. Her special interests include preventive cardiology, mechanisms of coronary artery disease, heart disease risk assessment, and heart disease women and in the young.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05646381
Phase
Phase 2 Aortic Stenosis Research Study
Study Type
Interventional
Participants
Expecting 502 study participants
Last Updated