RecruitingPhase 2NCT05646381
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
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]
Sponsor
Novartis Pharmaceuticals
Enrollment
502 participants
Start Date
Mar 7, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 50 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
DRUGPelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
DRUGMatching placebo
Matching placebo
Locations(136)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05646381
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