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

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ClinicalTrials.gov Identifier: NCT04023552
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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
Cardiovascular Disease and Lipoprotein(a) Drug: TQJ230 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : June 7, 2024
Estimated Study Completion Date : June 10, 2024
Arms and Interventions
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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 Name: Placebo to match TQJ230


Outcome Measures
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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 [ Time Frame: approximately 4 years ]
    Demonstrate the superiority of 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. [ Time Frame: approximately 4 years ]
    Demonstrate the superiority of 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) [ Time Frame: approximately 4 years ]
    Demonstrate the superiority of 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 [ Time Frame: approximately 4 years ]
    Demonstrate the superiority of 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 [ Time Frame: approximately 4 years ]
    Evaluation by clinical endpoint committee the rate of all-cause death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023552


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04023552    
Other Study ID Numbers: CTQJ230A12301
CTQJ230A12301 ( Other Identifier: Novartis )
2019-001076-11 ( EudraCT Number )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Lipoprotein(a), Lp(a),CVD, myocardial infarction, PAD,Stroke
Additional relevant MeSH terms:
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Cardiovascular Diseases