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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Cardiovascular Disease and Lipoprotein(a)

Intervention / Treatment
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* Drug: TQJ230
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQJ230<br>TQJ230 80 mg injected monthly administered subcutaneously | Drug: TQJ230<br>* TQJ230 80 mg injected monthly administered subcutaneously<br>|
| Placebo Comparator: Placebo<br>Monthly subcutaneous injections. | Drug: Placebo<br>* Placebo to match TQJ230 prefilled syringe to be injected subcutaneously<br>* Other names: Placebo to match TQJ230;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL | 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) | approximately 4 years | 
| 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. | 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) | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | approximately 4 years | 
| 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 | 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. | approximately 4 years | 
| Number of participants with confirmed all-cause death | Evaluation by clinical endpoint committee the rate of all-cause death | approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipoprotein(a), Lp(a),CVD, myocardial infarction, PAD,Stroke, Pelacarsen