©2024 Stanford Medicine
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Not 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)
Abha Khandelwal
Clinical Associate 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
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305