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

Phase 3Active Not RecruitingNCT04023552

Novartis Pharmaceuticals8,323 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

8,323

Conditions

Cardiovascular Disease and Lipoprotein(a)

Interventions

TQJ230DRUG

TQJ230 80 mg injected monthly administered subcutaneously

PlaceboDRUG

Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (904)

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: approximately 4 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: approximately 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

SEC Clinical Research LLC

Andalusia, Alabama, United States

Grandview Med Group Research LLC

Birmingham, Alabama, United States

Novartis Investigative Site

Birmingham, Alabama, United States

Heart Center Research Llc

Huntsville, Alabama, United States

Novartis Investigative Site

Huntsville, Alabama, United States

Mobile Heart Specialists

Mobile, Alabama, United States

Novartis Investigative Site

Mobile, Alabama, United States

Novartis Investigative Site

Cottonwood, Arizona, United States

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Clinical Research Inst of Arizona

Sun City West, Arizona, United States

...and 894 more locations