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Trial record 1 of 19 for:    Novartis Horizon
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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 : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE December 12, 2019
Estimated Primary Completion Date April 3, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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.
  • 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.
  • Number of participants with confirmed all-cause death [ Time Frame: approximately 4 years ]
    Evaluation by clinical endpoint committee the rate of all-cause death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Disease and Lipoprotein(a)
Intervention  ICMJE
  • Drug: TQJ230
    TQJ230 80 mg injected monthly administered subcutaneously
  • Drug: Placebo
    Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
    Other Name: Placebo to match TQJ230
Study Arms  ICMJE
  • Experimental: TQJ230
    TQJ230 80 mg injected monthly administered subcutaneously
    Intervention: Drug: TQJ230
  • Placebo Comparator: Placebo
    Monthly subcutaneous injections.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
7680
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 3, 2024
Estimated Primary Completion Date April 3, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria Lp(a) ≥ 70 mg/dL at the screening visit Optimal LDL-cholesterol lowering treatment Optimal treatment of other CV risk factors Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit Ischemic stroke: ≥ 3 months 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023552
Other Study ID Numbers  ICMJE CTQJ230A12301
CTQJ230A12301 ( Other Identifier: Novartis )
2019-001076-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP