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

Trial ID or NCT#

NCT05646381

Status

recruiting iconRECRUITING

Purpose

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]

Eligibility Criteria

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
    1. Other protocol-defined inclusion/exclusion criteria may apply
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Investigator(s)

Abha Khandelwal
Abha Khandelwal
Cardiologist, Obstetrics cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine

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Contact

Novartis Pharmaceuticals
1-888-669-6682

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View on ClinicalTrials.gov