Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05537948

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Dyslipidemias Hydroxymethylglutaryl-CoA Reductase Inhibitors Hyperlipidemias Immunosuppression Lipid Metabolism Disorders Liver Transplant Disorder Metabolic Diseases Nutritional and Metabolic Diseases Statins

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia

Moscow, 101000, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pitavastatin

Drug

First phase (6 months):

Patients will be randomized 1:1 into 2 groups:

  • pitavastatin monotherapy
  • monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously)

In the group of Pitavastatin: Pitavastatin at visit 0 will be prescribed at a dose of 2 mg, after 1 month in the absence of side effects against the background of ongoing therapy, the dose will be increased to 4 mg.

The lipid profile and safety of the therapy will be assessed in 1, 3 and 6 months after the start of the therapy.

When triglyceride levels rise above 5.7 mmol/l in two consecutive analyzes, the addition of fenofibrate may be considered.

Second phase (6 months):

If the target level of LDL-C is not achieved during monotherapy with pitavastatin, the patient will be asked to continue treatment with combined lipid-lowering therapy (pitavastatin + PCSK9 inhibitor). There will be visits on the 7th, 9th and 12th months.

PCSK9 inhibitor

Drug

First phase (6 months):

Patients will be randomized 1:1 into 2 groups:

  • pitavastatin monotherapy
  • monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously)

In the group of PCSK9 inhibitors:The lipid profile and safety of the therapy will be assessed in 1, 3 and 6 months after the start of the therapy.

When triglyceride levels rise above 5.7 mmol/l in two consecutive analyzes, the addition of fenofibrate may be considered.

Second phase (6 months):

If the target level of LDL-C is not achieved during monotherapy with a PCSK9 inhibitor, the patient will be asked to continue treatment with combined lipid-lowering therapy (pitavastatin + PCSK9 inhibitor). Pitavastatin will initially be prescribed at a dose of 2 mg, after 1 month. in the absence of side effects against the background of ongoing therapy, the dose will be increased to 4 mg. There will be visits on the 7th, 9th and 12th months.

Primary outcomes

  1. absolute change in LDL-C from baseline by months 1 and 3 of study therapy

    Time frame: months 1 and 3 of study therapy

    absolute change in LDL-C from baseline

  2. percent change in LDL-C from baseline at months 1 and 3 of study therapy

    Time frame: months 1 and 3 of study therapy

    percent change in LDL-C from baseline

  3. the proportion of patients who have reached the target level of LDL-C by month 1 of study therapy

    Time frame: month 1 of study therapy

    the proportion of patients who have reached the target level of LDL-C

  4. the proportion of patients who have reached the target level of LDL-C by month 3 of study therapy

    Time frame: month 3 of study therapy

    the proportion of patients who have reached the target level of LDL-C

Secondary outcomes

  1. the timing of achieving the target level of LDL-C at months 1, 3, 6, 7, 9, 12 of study therapy

    Time frame: months 1, 3, 6, 7, 9, 12 of study therapy

    the timing of achieving the target level of LDL-C

  2. percent of patients with target level of LDL-C at months 6 and 12 of study therapy

    Time frame: months 6 and 12 of study therapy

    percent of patients with target level of LDL-C

Other outcomes

  1. the proportion of patients with increased level of creatine phosphokinase (more than 4 times of the upper limit normal (ULN)) at months 1, 3, 6, 7, 9, 12 of study therapy

    Time frame: months 1, 3, 6, 7, 9, 12 of study therapy

    the proportion of patients with increased level of creatine phosphokinase (more than 4 times of the upper limit normal (ULN))

  2. the proportion of patients with increase higer than the upper limit normal (ULN) of one of the parameters in blood: ALT, AST, GGT, alkaline phosphatase, total bilirubin at months 1, 3, 6, 7, 9, 12 of study therapy

    Time frame: months 1, 3, 6, 7, 9, 12 of study therapy

    the proportion of patients with increase higer than the upper limit normal (ULN) of one of the parameters in blood: ALT, AST, GGT, alkaline phosphatase, total bilirubin

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Acronym: PINTL

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 13, 2022
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.