NCT05976893

Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Xiang Xie · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, open-label, and single center trial. To evaluate the effect of treatment with PCSK9 inhibitor on the risk for cardiovascular death, recurrent unstable angina, myocardial infarction, stroke, or coronary revascularization in patients with very high risk of atherosclerotic cardiovascular disease (ASCVD) and cancer.

Detailed description

Subjects will be randomly assigned in a 1:1 ratio to receive subcutaneous injections of PCSK9 inhibitor (evolocumab:420 mg every 4 weeks) plus moderate intensity statin therapy or the statin alone therapy. After randomization, patients will come to the hospital every 4 weeks to collect relevant laboratory results and clinical outcomes, and be detected by echocardiography and carotid ultrasound every 12 weeks until the end of follow-up at week 48 or the occurrence of an endpoint event. The entire study is expected to be conducted for 3 years, with a recruitment period of 2 years.

Conditions

• ASCVD
• Atherosclerotic Cardiovascular Disease
• Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
• Cancer

Interventions

Type	Name	Description
DRUG	Evolocumab	Evolocuma:420 mg every 4 weeks
DRUG	Statin	The moderate intensity statins used during the study are one of atorvastatin 10-20mg qd, resuvastatin 5-10mg qd, and xuezhikang 0.6g bid (statin intolerance).

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-04
• Last updated: 2023-08-04

Regulatory

• FDA-regulated drug study