Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Phase 3 – large-scale trial before approval
Conditions:
Cardiovascular Disease and Lipoprotein(a)
Sponsor: Novartis Pharmaceuticals
trial.available_in:
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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)
Who can participate
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.
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