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

NCT05646381

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Aortic Stenosis

Interventions: Pelacarsen (TQJ230) 80mg, Matching placebo

Countries: United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 50 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male and female ≥50 to \<80 years of age at Screening Part II
* 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
Locations (140)
  • Huntsville, Alabama, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Covina, California, United States
  • Northridge, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Boca Raton, Florida, United States
  • Bradenton, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Naples, Florida, United States
  • Overland Park, Kansas, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • Flint, Michigan, United States
  • Royal Oak, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • Summit, New Jersey, United States
  • Albany, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • + 110 more on CT.gov