Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients
Status:
Recruiting
Trial end date:
2020-12-14
Target enrollment:
Participant gender:
Summary
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type
9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of
cardiovascular events. Whether evolcumab is effective in haemodialized patients is uncertain.
The investigators will conduct a randomized, double-blind, placebo-controlled trial to assess
the feasibility, safety, and LDL-C-lowering efficacy of evolocumab in high cardiovascular
risk haemodialized statin intolerant patients with hypercholesterolemia. Patients will be
randomly assigned to receive evolocumab (140 mg subcutaneous every 2 weeks + ezetimibe 10 mg
per os daily) or matching placebo (subcutaneous every 2 weeks + ezetimibe 10 mg per os daily)
for 24 weeks. The primary efficacy end point will be the reduction in LDL-C ≥ 20 mg/dL from
baseline. The key secondary efficacy end points will be: the reduction of LDL-C from baseline
at 4, 6 and 12 weeks; the reduction of HDL-C, non-HDL cholesterol and triglycerides from
baseline at 24 weeks; the number of patients achieving LDL-C <70 mg/dL. Every adverse event
(serious and non-serious) correlated to drug infusion will be recorded (safety end-point).