Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors... | NCT05537948

Status Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pitavastatin	Active Comparator	Pitavastatin 2 mg/d - 4 mg/d	Drug: Pitavastatin
PCSK9 Inhibitors	Active Comparator	Evolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks	Drug: PCSK9 inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
absolute change in LDL-C from baseline by months 1 and 3 of study therapy	absolute change in LDL-C from baseline	months 1 and 3 of study therapy
percent change in LDL-C from baseline at months 1 and 3 of study therapy	percent change in LDL-C from baseline	months 1 and 3 of study therapy
the proportion of patients who have reached the target level of LDL-C by month 1 of study therapy	the proportion of patients who have reached the target level of LDL-C	month 1 of study therapy
the proportion of patients who have reached the target level of LDL-C by month 3 of study therapy	the proportion of patients who have reached the target level of LDL-C	month 3 of study therapy

Secondary Outcomes

Measure	Description	Time Frame
the timing of achieving the target level of LDL-C at months 1, 3, 6, 7, 9, 12 of study therapy	the timing of achieving the target level of LDL-C	months 1, 3, 6, 7, 9, 12 of study therapy
percent of patients with target level of LDL-C at months 6 and 12 of study therapy

Other Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Alexandra Ershova, PhD	National Medical Research Centre for Therapy and Preventive Medicine Ministry of Health of Russia	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia		Moscow		101000	Russia

IPD Sharing Statement Module

ID	Term
D050171	Dyslipidemias
D006949	Hyperlipidemias

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases