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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 : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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 : March 1, 2024
Estimated Study Completion Date : March 1, 2024

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




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



Information from the National Library of Medicine

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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 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.


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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United States, Alabama
Novartis Investigative Site Recruiting
Andalusia, Alabama, United States, 36420
United States, Arizona
Novartis Investigative Site Recruiting
Cottonwood, Arizona, United States, 86326
Novartis Investigative Site Recruiting
Surprise, Arizona, United States, 85374
Novartis Investigative Site Recruiting
Tucson, Arizona, United States, 85745
United States, California
Novartis Investigative Site Recruiting
West Hills, California, United States, 91307
United States, Florida
Novartis Investigative Site Recruiting
Boca Raton, Florida, United States, 33434
Novartis Investigative Site Recruiting
Bradenton, Florida, United States, 34209
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32216
Novartis Investigative Site Recruiting
Naples, Florida, United States, 34102
Novartis Investigative Site Recruiting
Port Charlotte, Florida, United States, 33952
United States, Louisiana
Novartis Investigative Site Recruiting
Covington, Louisiana, United States, 70433
Novartis Investigative Site Recruiting
Hammond, Louisiana, United States, 70403
Novartis Investigative Site Recruiting
Houma, Louisiana, United States, 70360
Novartis Investigative Site Recruiting
Metairie, Louisiana, United States, 70006
United States, Nebraska
Novartis Investigative Site Recruiting
Omaha, Nebraska, United States, 68134
United States, Tennessee
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37917
United States, Texas
Novartis Investigative Site Recruiting
Livingston, Texas, United States, 77351
Novartis Investigative Site Recruiting
Tomball, Texas, United States, 77375
United States, Utah
Novartis Investigative Site Recruiting
Bountiful, Utah, United States, 84010
Novartis Investigative Site Recruiting
Layton, Utah, United States, 84041
United States, Virginia
Novartis Investigative Site Recruiting
Falls Church, Virginia, United States, 22042
Novartis Investigative Site Recruiting
Manassas, Virginia, United States, 20109
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10787
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Dresden, Germany, 01069
Novartis Investigative Site Recruiting
Dresden, Germany, 01277
Novartis Investigative Site Recruiting
Loehne, Germany, 32584
Novartis Investigative Site Recruiting
Mannheim, Germany, 68165
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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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: May 15, 2020
Last Verified: May 2020
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