Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia
Status:
Recruiting
Trial end date:
2021-12-30
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 proportion of patients that will
reduce LDL-C < 55 mg/dL in the evolocumab group compared to placebo at 24 weeks. 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. Every adverse event (serious and non-serious) correlated to drug infusion will be
recorded (safety end-point).