NCT05537948

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: National Medical Research Center for Therapy and Preventive Medicine · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemias
• Hyperlipidemias
• Liver Transplant Disorder
• Immunosuppression
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Statins

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-01-31
• Completion: 2025-01-31
• First posted: 2022-09-13
• Last updated: 2025-01-22

Locations

1 site across 1 country: Russia