Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients (PINTL)

National Medical Research Center for Therapy and Preventive Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Hyperlipidemias; Dyslipidemias; Statins; Liver Transplant Disorder; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunosuppression

Treatments: Drug: PCSK9 inhibitor; Drug: Pitavastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05537948

2.0_17.03.22

Details and patient eligibility

About

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

Full description

1. Evaluate the efficacy and safety of lipid-lowering therapy in real clinical practice.
2. To evaluate the efficacy and safety of pitavastatin in patients undergoing liver transplantation and receiving immunosuppressive therapy.
3. Evaluate the efficacy and safety of PCSK9 inhibitors in patients undergoing liver transplantation and receiving immunosuppressive therapy.
4. To compare the efficacy and safety of pitavastatin and a PCSK9 inhibitor in patients undergoing liver transplantation and receiving immunosuppressive therapy.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

pitavastatin

Active Comparator group

Description:

Pitavastatin 2 mg/d - 4 mg/d

Treatment:

Drug: Pitavastatin

PCSK9 Inhibitors

Active Comparator group

Description:

Evolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks

Treatment:

Drug: PCSK9 inhibitor