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

• Status: Recruiting
• Trial end date: 2024-06-27
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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.