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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2025

Conditions
DyslipidemiasHyperlipidemiasLiver Transplant DisorderImmunosuppressionHydroxymethylglutaryl-CoA Reductase InhibitorsStatins
Interventions
DRUG

Pitavastatin

"First phase (6 months):~Patients will be randomized 1:1 into 2 groups:~1. pitavastatin monotherapy~2. 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."

DRUG

PCSK9 inhibitor

"First phase (6 months):~Patients will be randomized 1:1 into 2 groups:~1. pitavastatin monotherapy~2. 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."

Trial Locations (1)

101000

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

All Listed Sponsors
lead

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV