A multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with cardiovascular disease.

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 (CVD).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001076-11-AT

Enrollment

8280

Registered

2019-11-27

Start date

2020-03-11

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease MedDRA version: 21.1 Level: LLT Classification code 10051614 Term: Arteriosclerotic cardiovascular disease System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Pelacarsen Product Code: TQJ230 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Pelacarsen CAS Number: 1637637-70-7 Current Sponsor code: TQJ230 Co

Eligibility

Sex/Gender

All

Inclusion criteria

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 from screening and randomization visits to = 10 years prior to the screening visit, and/or - Ischemic stroke: = 3 months from screening and randomization visits to = 10 years prior to the screening visit - Clinically significant symptomatic peripheral artery disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3105

Exclusion criteria

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 <140,000 per mm3 - Active liver disease or hepatic dysfunction - Significant kidney disease - Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study is to 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 1) the overall study population with established CVD (Lp(a) = 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) = 90 mg/dL. ;Secondary Objective: In the overall trial population and in subpopulation (= 90 mg/dL): Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke. 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, non-fatal MI and urgent coronary re-vascularization requiring hospitalization . Evaluate the rate of all cause death. Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year.;Primary end point(s): 1. Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated 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.;Timepoint(s) of evaluation of this end point: 4.25 years for both endpoints	—

Measure

Time frame

Main Objective: The primary objectives of this study is to 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 1) the overall study population with established CVD (Lp(a) = 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) = 90 mg/dL. ;Secondary Objective: In the overall trial population and in subpopulation (= 90 mg/dL): Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke. 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, non-fatal MI and urgent coronary re-vascularization requiring hospitalization . Evaluate the rate of all cause death. Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year.;Primary end point(s): 1. Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated 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.;Timepoint(s) of evaluation of this end point: 4.25 years for both endpoints

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Secondary

Measure	Time frame
Secondary end point(s): 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) 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 3.Change in Lp(a) in the log scale from baseline at 1 year 4.Time to CEC confirmed all-cause death;Timepoint(s) of evaluation of this end point: 4.25 years for the 3 endpoints 1, 2 and 4 1 year for endpoint 3	—

Measure

Time frame

Secondary end point(s): 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) 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 3.Change in Lp(a) in the log scale from baseline at 1 year 4.Time to CEC confirmed all-cause death;Timepoint(s) of evaluation of this end point: 4.25 years for the 3 endpoints 1, 2 and 4 1 year for endpoint 3

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactDrug Regulatory Affairs

Novartis Pharma GmbH

austria.dra@novartis.com+43 1 86657 0

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026