> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-multicenter-trial-assessing-the-impact-of-lipoprotein-a-51773799-ce02-463c-ae31-aa417295a17d > Record changed: 2026-10-13 # A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis NCT05646381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Participants 502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Start date 2024-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) Number of sites 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Short title** A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **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 \[Lp(a)FRONTIERS CAVS\] Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Dates **Completion date** 2030-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **First posted** 2022-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Registry last updated** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Primary completion date** 2030-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Start date** 2024-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Size and sites **Participants** 502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Planned participants** 502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Number of sites** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Identifiers **Registry ID** NCT05646381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **ClinicalTrials.gov ID** NCT05646381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Double-blind study **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Outcomes ### Primary outcomes 1. Change in peak aortic jet velocity Timeframe: 36 months To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography 2. Change in aortic valve calcium score Timeframe: 36 months To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography ### Secondary outcomes 1. Change in Lp(a) levels Timeframe: 12 months To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12 2. Change in fibrocalcific thickening of the aortic valve Timeframe: 36 months To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT 3. Time from randomization to first occurrence of composite clinical endpoint event Timeframe: Up to 36 months To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: 1\. Unplanned CAVS related hospital admission 2\. Aortic valve intervention 3\. Death related to calcific aortic valve stenosis Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 80 Years **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 - Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Sites - Heart Center Research LlcHuntsville, United StatesRecruiting - Cardiovascular Res FoundBeverly Hills, United StatesRecruiting - National Heart InstituteBeverly Hills, United StatesRecruiting - Flourish Clinical Resrch CovinCovina, United StatesRecruiting - Valley Clinical TrialsNorthridge, United StatesRecruiting - Stanford University Medical CenterPalo Alto, United StatesRecruiting - University Of California San DiegoSan Diego, United StatesRecruiting - UC San Francisco Medical CenterSan Francisco, United StatesRecruiting - Excel Medical Clinical Trials LLCBoca Raton, United StatesWithdrawn - Nova Clinical Research LLCBradenton, United StatesRecruiting - Flourish Res Acq LLC North MiamiMiami, United StatesRecruiting - Inpatient Research Clinical LLCMiami Lakes, United StatesRecruiting - Advanced Research for Health Improvement LLCNaples, United StatesWithdrawn - Midwest Heart and Vascular SpecOverland Park, United StatesRecruiting - Tufts Medical CenterBoston, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Brigham and Womens Hosp Harvard Med SchoolBoston, United StatesRecruiting - Brigham and Womens Hosp Harvard Med SchoolBoston, United StatesRecruiting - Henry Ford HospitalDetroit, United StatesRecruiting - Henry Ford HospitalDetroit, United StatesRecruiting - AA Medical Research CenterFlint, United StatesRecruiting - William Beaumont HospitalRoyal Oak, United StatesRecruiting - Minneapolis Heart InstituteMinneapolis, United StatesWithdrawn - University Of MinnesotaMinneapolis, United StatesRecruiting And 115 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## References - PubMed 42592935 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42592935/) Related publication - PubMed 39329200 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39329200/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05646381) ## Related records ### Drugs (1) - [Pelacarsen sodium](https://trialight.com/data/asset/pelacarsen-sodium-24b0b702-cc3c-464c-a8d6-28bf8b369e0b.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Conditions (1) - [Aortic valve stenosis](https://trialight.com/data/condition/aortic-valve-stenosis-d3f1a482-d908-5993-8a6c-7daad057bb89.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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