DyslipidemiasPhase 4PINTLNCT05537948
Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients
A Phase 4 study testing Pitavastatin and PCSK9 inhibitor in people with Dyslipidemias and Hyperlipidemias, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder
- What is being tested?
- Pitavastatin and PCSK9 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2021to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of Russia
Moscow, 101000
About this study
To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.
Read the detailed description
- 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.
- Conditions
- Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder, Immunosuppression, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Statins
- Being tested
- Pitavastatin, PCSK9 inhibitor
- Keywords
- Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder, Immunosuppression, Immunosuppressive therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors, pitavastatin, statins, PCSK9, PCSK9 Inhibitors, evolocumab, alirocumab
- Medical subject headings
- Dyslipidemias, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
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 inhibitorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| pitavastatin | Active comparator | Pitavastatin 2 mg/d - 4 mg/d Receives: Drug: Pitavastatin |
| PCSK9 Inhibitors | Active comparator | Evolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks Receives: Drug: PCSK9 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute change in LDL-C from baseline by months 1 and 3 of study therapy
absolute change in LDL-C from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: month 3 of study therapy
Secondary outcomes (2)
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
Measured: 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
percent of patients with target level of LDL-C
Measured: months 6 and 12 of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Oct 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase 1: randomized, prospective, single-center, parallel-group study phase 2: observational study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexandra Ershova, PhD, Study chair, National Medical Research Centre for Therapy and Preventive Medicine Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537948
- Sponsor's protocol ID
- 2.0_17.03.22
- Acronym
- PINTL
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT05537948
- Acronym / sponsor ID
- PINTL / 2.0_17.03.22
- Conditions
- Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder, Immunosuppression, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Statins
- Keywords
- Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder, Immunosuppression, Immunosuppressive therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors, pitavastatin, statins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- phase 1: randomized, prospective, single-center, parallel-group study phase 2: observational study
| Arm | Type | Receives |
|---|---|---|
| pitavastatin | Active comparator | Drug: PitavastatinPitavastatin 2 mg/d - 4 mg/d |
| PCSK9 Inhibitors | Active comparator | Drug: PCSK9 inhibitorEvolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitavastatinFirst 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 | pitavastatin |
| PCSK9 inhibitorFirst 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. | Drug | PCSK9 Inhibitors |
Primary outcome
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
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
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
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Ershova, PhD study chair
National Medical Research Centre for Therapy and Preventive Medicine Ministry of Health of Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin and PCSK9 inhibitor in people with Dyslipidemias and Hyperlipidemias, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute change in LDL-C from baseline by months 1 and 3 of study therapy (time frame: months 1 and 3 of study therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.