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]
Novartis Pharmaceuticals
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.
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugPelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
- DrugMatching placebo
Matching placebo
Locations (139)
- Heart Center Research LlcHuntsville, Alabama
- Cardiovascular Res FoundBeverly Hills, California
- National Heart InstituteBeverly Hills, California
- Flourish Clinical Resrch CovinCovina, California
- Valley Clinical TrialsNorthridge, California
- Stanford University Medical CenterPalo Alto, California