Lp(a)HORIZON: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04023552
Collaborator
(none)
7,680
793
2
65.6
9.7
0.1

Study Details

Study Description

Brief Summary

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
7680 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease
Actual Study Start Date :
Dec 12, 2019
Anticipated Primary Completion Date :
May 29, 2025
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TQJ230

TQJ230 80 mg injected monthly administered subcutaneously

Drug: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously

Placebo Comparator: Placebo

Monthly subcutaneous injections.

Drug: Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
Other Names:
  • Placebo to match TQJ230
  • Outcome Measures

    Primary Outcome Measures

    1. Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL [approximately 4 years]

      Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)

    2. Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL. [approximately 4 years]

      Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)

    Secondary Outcome Measures

    1. Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke) [approximately 4 years]

      Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.

    2. Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization [approximately 4 years]

      Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.

    3. Number of participants with confirmed all-cause death [approximately 4 years]

      Evaluation by clinical endpoint committee the rate of all-cause death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Key Inclusion Criteria

    • Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory

    • Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit

    • Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit

    • Clinically significant symptomatic peripheral artery disease

    Key Exclusion Criteria

    • Uncontrolled hypertension

    • Heart failure New York Heart Association (NYHA) class IV

    • 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 at the end.

    Contacts and Locations

    Locations

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    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04023552
    Other Study ID Numbers:
    • CTQJ230A12301
    • CTQJ230A12301
    • 2019-001076-11
    First Posted:
    Jul 17, 2019
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022