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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04023552
Other study ID # CTQJ230A12301
Secondary ID CTQJ230A12301201
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 12, 2019
Est. completion date May 30, 2025

Study information

Verified date May 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8323
Est. completion date May 30, 2025
Est. primary completion date May 29, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Locations

Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Capital Federal
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Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site San Luis
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Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  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,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Time to Clinical endpoint Committee confirmed all-cause death Evaluation by clinical endpoint committee the rate of all-cause death approximately 4 years
Secondary Change in Lp(a) in the log scale from baseline Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year Baseline, year 1
See also
  Status Clinical Trial Phase
Completed NCT03887520 - Lipoprotein(a) in Patients With Cardiovascular Disease (CVD) N/A