A Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Cardiovascular Disease

• Status: Active, not recruiting
• Trial end date: 2024-07-04
• 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: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Lp(a) ≥ 70 mg/dL at the screening visit

• Optimal LDL-cholesterol lowering treatment

• Optimal treatment of other CV risk factors

• Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or

• Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or

• Clinically significant symptomatic peripheral artery disease

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 <140,000 per μL

• Active liver disease or hepatic dysfunction