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Completed NCT04023552

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

Conditions: Cardiovascular Disease and Lipoprotein(a)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 8323
Sponsor: Novartis Pharmaceuticals

Location: SEC Clinical Research LLC Andalusia Alabama

Summary

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)

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04023552). StuddyBuddy aggregates publicly available trial information.