search
Back to results

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

Primary Purpose

Aortic Stenosis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pelacarsen (TQJ230) 80mg
Matching placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Cardiovascular, Lipoprotein(a), Lp(a), Calcific aortic valve stenosis, TQJ230, Pelacarsen

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female ≥50 years of age Lp(a) ≥125 nmol/L at the screening visit, measured at the Central laboratory Mild or moderate calcific aortic valve stenosis 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pelacarsen (TQJ230) 80mg

    Matching placebo

    Arm Description

    Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously

    Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

    Outcomes

    Primary Outcome Measures

    Change in peak aortic jet velocity
    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
    Change in aortic valve calcium score
    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 Outcome Measures

    Change in Lp(a) levels
    To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
    Change in fibrocalcific thickening of the aortic valve
    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
    Time from randomization to first occurrence of composite clinical endpoint event
    To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: Hospitalization due to symptoms of CAVS Requirement of AVI Death related to CAVS

    Full Information

    First Posted
    December 2, 2022
    Last Updated
    July 24, 2023
    Sponsor
    Novartis Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05646381
    Brief Title
    A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
    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]
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 27, 2024 (Anticipated)
    Primary Completion Date
    September 5, 2028 (Anticipated)
    Study Completion Date
    December 26, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Stenosis
    Keywords
    Cardiovascular, Lipoprotein(a), Lp(a), Calcific aortic valve stenosis, TQJ230, Pelacarsen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blind study
    Allocation
    Randomized
    Enrollment
    502 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pelacarsen (TQJ230) 80mg
    Arm Type
    Experimental
    Arm Description
    Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
    Arm Title
    Matching placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
    Intervention Type
    Drug
    Intervention Name(s)
    Pelacarsen (TQJ230) 80mg
    Other Intervention Name(s)
    TQJ230
    Intervention Description
    Pelacarsen (TQJ230) 80mg
    Intervention Type
    Drug
    Intervention Name(s)
    Matching placebo
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    Change in peak aortic jet velocity
    Description
    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
    Time Frame
    36 months
    Title
    Change in aortic valve calcium score
    Description
    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
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Change in Lp(a) levels
    Description
    To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
    Time Frame
    12 months
    Title
    Change in fibrocalcific thickening of the aortic valve
    Description
    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
    Time Frame
    36 months
    Title
    Time from randomization to first occurrence of composite clinical endpoint event
    Description
    To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: Hospitalization due to symptoms of CAVS Requirement of AVI Death related to CAVS
    Time Frame
    Up to 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female ≥50 years of age Lp(a) ≥125 nmol/L at the screening visit, measured at the Central laboratory Mild or moderate calcific aortic valve stenosis 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Novartis Pharmaceuticals
    Phone
    1-888-669-6682
    Email
    novartis.email@novartis.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Novartis Pharmaceuticals
    Phone
    +41613241111
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs