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 UCSF
Dates
study started
completion around
Principal Investigator
by Sammy Elmariah (ucsf)
Headshot of Sammy Elmariah
Sammy Elmariah

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, Pathologic Constriction, 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

  • UC San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • Cardiovascular Res Found accepting new patients
    Beverly Hills California 90210 United States
  • National Heart Institute accepting new patients
    Beverly Hills California 90211 United States
  • Valley Clinical Trials accepting new patients
    Northridge California 91325 United States

Lead Scientist at University of California Health

  • Sammy Elmariah (ucsf)
    Dr. Sammy Elmariah is an interventional cardiologist who specializes in caring for patients with heart valve disease, coronary artery disease, and adult congenital heart disease.

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