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

NCT05646381
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
502
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Lead sponsor
Novartis Pharmaceuticals
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Start date
2024-03-07
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Number of sites
140
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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.
clinicaltrials.gov
Short title
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
clinicaltrials.gov
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]
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2030-03-12
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First posted
2022-12-12
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Registry last updated
2026-06-23
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Primary completion date
2030-03-12
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Start date
2024-03-07
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Participants
502
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Participant count basis
Estimated
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Planned participants
502
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Protocol amendments
2
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Number of sites
140
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Novartis Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05646381
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ClinicalTrials.gov ID
NCT05646381
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
Double-blind study
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)