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 San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Sammy Elmariah
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

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stanford University Medical Center accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSF

  • Sammy Elmariah
    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
Contact us about this trial