Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
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
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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
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 Endpoints
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 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 to Clinical endpoint Committee confirmed all-cause death
Eligibility Criteria
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.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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