Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Treatments: Pitavastatin

Criteria

Inclusion Criteria:

• signed informed consent to participate in the study;

• a history of liver transplantation for any reason;

• immunosuppressive therapy;

• the presence of hyperlipidemia, requiring the prescription of lipid-lowering therapy according to the clinical guidelines of the European Society for the Study of Atherosclerosis (EAS) 2019

• failure to achieve the target level of LDL-C against the background of current lipid-lowering therapy;

• if the patient within 1 month before randomization took lipid-lowering therapy, then the absence of side effects against the background of previous lipid-lowering therapy.

Exclusion Criteria:

• treatment with PCSK9 in previous 6 months;

• current treatment in the form of lipoprotein apheresis;

• heart failure IV NYHA;

• active infectious disease, severe hematological, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction) at the time of the screening or randomization visits;

• the presence of an oncological disease, with the exception of hepatocellular carcinoma, which served as the reason for liver transplantation;

• CFR<15ml/min/1,73m2;

• pregnancy and breastfeeding.