Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients
- Conditions
- DyslipidemiasHyperlipidemiasLiver Transplant DisorderImmunosuppressionHydroxymethylglutaryl-CoA Reductase InhibitorsStatins
- Interventions
- Drug: PCSK9 inhibitor
- Registration Number
- NCT05537948
- Brief Summary
To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 59
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCSK9 Inhibitors PCSK9 inhibitor Evolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks pitavastatin Pitavastatin Pitavastatin 2 mg/d - 4 mg/d
- Primary Outcome Measures
Name Time Method absolute change in LDL-C from baseline by months 1 and 3 of study therapy months 1 and 3 of study therapy absolute change in LDL-C from baseline
percent change in LDL-C from baseline at months 1 and 3 of study therapy months 1 and 3 of study therapy percent change in LDL-C from baseline
the proportion of patients who have reached the target level of LDL-C by month 1 of study therapy month 1 of study therapy the proportion of patients who have reached the target level of LDL-C
the proportion of patients who have reached the target level of LDL-C by month 3 of study therapy month 3 of study therapy the proportion of patients who have reached the target level of LDL-C
- Secondary Outcome Measures
Name Time Method the timing of achieving the target level of LDL-C at months 1, 3, 6, 7, 9, 12 of study therapy months 1, 3, 6, 7, 9, 12 of study therapy the timing of achieving the target level of LDL-C
percent of patients with target level of LDL-C at months 6 and 12 of study therapy months 6 and 12 of study therapy percent of patients with target level of LDL-C
Trial Locations
- Locations (1)
National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia
🇷🇺Moscow, Russian Federation