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Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Recruiting
Trial ID: NCT04023552
Purpose
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)
Official Title
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
Stanford Investigator(s)
Eleanor Levin
Clinical Professor, Medicine - Cardiovascular Medicine
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.
Intervention(s):
drug: TQJ230
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305