DyslipidemiasCombi-LLT ACSNCT05624658
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
A study testing Combined Lipid-lowering Therapy in people with Dyslipidemias, run by Samara Regional Cardiology Dispensary at 1 site in Russia.
Trial summary
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( > 1.4… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Combined Lipid-lowering Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 2 Sep 2022to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- gender (any);
- age 18-75 years;
- admission < 24 hours after pain onset
- acute coronary syndrome with at least one coronary artery stenosis requiring PCI;
- one or two non-IRA (coronary artery lumen diameter according to CAG >20% and <50% and no need for revascularization within the next 6 months according to the investigator)
- not taking statins for at least 3 (6) months or not achieving the target level of LDL-C at admission
- failure to achieve the target level of LDL-C ≥1.4 mmol/l on the second visit;
- signed informed consent
Who cannot join
- previous MI
- history of revascularization (PCI/CABG)
- presence of non-IRA stenoses ≥50%.
- multivessel lesion, including significant stenosis of the LM
- EF < 40%,
- Killip III-IV.
Show all 16Show fewer
- NYHA III-IV
- significant calcification or tortuosity of the coronary arteries, limiting OCT
- intolerance to statins, aspirin, P2Y12 inhibitors
- patients who have previously received PCSK9 inhibitors and/or Ezetimib
- treatment with systemic steroids or systemic cyclosporine within the last 3 months
- collagenoses and inflammatory diseases,
- oncological diseases within the last 5 years,
- scheduled surgery within 3 months
- persons suffering from mental disorders
- pregnancy, breastfeeding period
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Samara Regional Cardiology Dispansery
Samara, 443070
Dmitry Duplyakov
Anna Kovalskaya
About this study
Official title: Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With Acute Coronary Syndrome, a Prospective, Open-label, Randomized, Single-center Study
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( > 1.4 mmol/l) despite statin therapy at the highest dosage. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Read the detailed description
The study will enroll 120 patients with ACS admitted on an emergency basis to the Hospital. All patients will undergo PCI of the infarct-related artery (IRA), as well as intracoronary imaging with OCT of one or two non-IRA. During hospitalization, patients will receive standard therapy of ACS according to clinical recommendations, while Atorvastatin will initially be prescribed at a maximum dosage of 80 mg / day. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Also, on the 2nd visit, patients will undergo coronary artery computed tomography (CCTA): assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile).
Follow up duration will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, CAVI index and laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL).
- Conditions
- Dyslipidemias
- Being tested
- Combined Lipid-lowering Therapy
- Keywords
- acute coronary syndrome, PCI, plaque vulnerability, combined lipid-lowering therapy, PCSK9 inhibitors, Ezetimibe, coronary artery computed tomography
- Medical subject headings
- Dyslipidemias, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Lipid-lowering TherapyCombination product
Also called invasive coronary angiography, coronary artery commputed tomography, OCT, CAVI index
the effect of high-dose combined lipid-lowering therapy (statins+ezetimibe vs statins+PCSK9 inhibitors) on the vulnerability characteristics of atherosclerotic plaques assessed using multimodal imaging (coronary artery computed tomography and optical coherence tomography), as well as biomarkers in patients with acute coronary syndrome for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PCSK9 inhibitors in combination Atorvastatin at a dose of 80 mg /Rosuvastatin 40 mg/ day | Active comparator | Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg./ Rosuvastatin 40 mg / day. Receives: Combination Product: Combined Lipid-lowering Therapy |
| Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/ day. | Active comparator | Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/day. Receives: Combination Product: Combined Lipid-lowering Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of change plaque vulnerability parameters on CCTA data
change plaque vulnerability parameterson coronary artery computed tomography in non-IRA coronary arteries (positive remodeling; the presence of a low-density area in the plaque (less than 30 HU *); point calcifications in the composition of the plaque; ring-shaped enhancement of X-ray density along the periphery of the plaque, not exceeding 130 HU, or the phenomenon of "circular glow")
Measured: 52 weeks
Secondary outcomes (9)
The number of participants with death, stent thrombosis/restenosis, nonfatal MI, hospitalization due to unstable angina, revascularization within 1 year
assessment via telemedicine consultation every month and at follow-up visits every 3 months
Measured: 52 weeks
Total cholesterol, LDL-C, HDL-C, triglycerides levels after 52 weeks
blood sampling at control visits every 3 months
Measured: 52 weeks
dynamics of level hs-Troponin I within 1 year (ng/l)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level hs-CRP within 1 year (mg/l)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level NLR within 1 year
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level Galectin- 3 within 1 year (ng/ml)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level MMP-9 within 1 year (ng/ml)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level TIMP - 1 within 1 year (ng/ml)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
dynamics of level NGAL within 1 year (ng/ml)
blood sampling at the second visit and 12 months later
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start2 Sep 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day. Also, on the 2nd visit, patients will undergo CCTA, an assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile). Follow-up period will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, assess the CAVI index and laboratory tests (blood count, lipid profile, Troponin I, Galectin-3, MMP-9, TIMP-1, high-sensitivity CRP, NGAL).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samara Regional Cardiology Dispensary
- Sponsor type
- University, hospital or other
- Collaborators
- Samara State Medical University
- Responsible party
- Principal investigator, Prof. Dmitry Duplyakov FESC, Samara Regional Cardiology Dispensary
- Investigators
- Dmitry Duplyakov, Principal investigator, Samara State Medical Universiry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624658
- Sponsor's protocol ID
- SamaraRCD-1
- Acronym
- Combi-LLT ACS
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With Acute Coronary Syndrome, a Prospective, Open-label, Randomized, Single-center Study
- ClinicalTrials.gov ID
- NCT05624658
- Acronym / sponsor ID
- Combi-LLT ACS / SamaraRCD-1
- Conditions
- Dyslipidemias
- Keywords
- acute coronary syndrome, PCI, plaque vulnerability, combined lipid-lowering therapy, PCSK9 inhibitors, Ezetimibe, coronary artery computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samara Regional Cardiology DispensaryUniversity, hospital or other
- Collaborators
- Samara State Medical University
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 22 Nov 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.
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( > 1.4 mmol/l) despite statin therapy at the highest dosage. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Detailed description
The study will enroll 120 patients with ACS admitted on an emergency basis to the Hospital. All patients will undergo PCI of the infarct-related artery (IRA), as well as intracoronary imaging with OCT of one or two non-IRA. During hospitalization, patients will receive standard therapy of ACS according to clinical recommendations, while Atorvastatin will initially be prescribed at a maximum dosage of 80 mg / day. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Also, on the 2nd visit, patients will undergo coronary artery computed tomography (CCTA): assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile).
Follow up duration will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, CAVI index and laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients who did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day. Also, on the 2nd visit, patients will undergo CCTA, an assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile). Follow-up period will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, assess the CAVI index and laboratory tests (blood count, lipid profile, Troponin I, Galectin-3, MMP-9, TIMP-1, high-sensitivity CRP, NGAL).
| Arm | Type | Receives |
|---|---|---|
| PCSK9 inhibitors in combination Atorvastatin at a dose of 80 mg /Rosuvastatin 40 mg/ day | Active comparator | Combination Product: Combined Lipid-lowering TherapyPatients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg./ Rosuvastatin 40 mg / day. |
| Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/ day. | Active comparator | Combination Product: Combined Lipid-lowering TherapyGroup 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- gender (any);
- age 18-75 years;
- admission < 24 hours after pain onset
- acute coronary syndrome with at least one coronary artery stenosis requiring PCI;
- one or two non-IRA (coronary artery lumen diameter according to CAG >20% and <50% and no need for revascularization within the next 6 months according to the investigator)
Key exclusion criteria (16 listed)
- previous MI
- history of revascularization (PCI/CABG)
- presence of non-IRA stenoses ≥50%.
- multivessel lesion, including significant stenosis of the LM
- EF < 40%,
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 |
|---|---|---|
| Combined Lipid-lowering TherapyAlso: invasive coronary angiography, coronary artery commputed tomography, OCT, CAVI indexthe effect of high-dose combined lipid-lowering therapy (statins+ezetimibe vs statins+PCSK9 inhibitors) on the vulnerability characteristics of atherosclerotic plaques assessed using multimodal imaging (coronary artery computed tomography and optical coherence tomography), as well as biomarkers in patients with acute coronary syndrome for 52 weeks. | Combination product | Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/ day., PCSK9 inhibitors in combination Atorvastatin at a dose of 80 mg /Rosuvastatin 40 mg/ day |
Primary outcome
Percent of change plaque vulnerability parameters on CCTA data
Time frame: 52 weeks
change plaque vulnerability parameterson coronary artery computed tomography in non-IRA coronary arteries (positive remodeling; the presence of a low-density area in the plaque (less than 30 HU *); point calcifications in the composition of the plaque; ring-shaped enhancement of X-ray density along the periphery of the plaque, not exceeding 130 HU, or the phenomenon of "circular glow")
9 secondary outcomes
The number of participants with death, stent thrombosis/restenosis, nonfatal MI, hospitalization due to unstable angina, revascularization within 1 year
Time frame: 52 weeks
Total cholesterol, LDL-C, HDL-C, triglycerides levels after 52 weeks
Time frame: 52 weeks
dynamics of level hs-Troponin I within 1 year (ng/l)
Time frame: 52 weeks
dynamics of level hs-CRP within 1 year (mg/l)
Time frame: 52 weeks
dynamics of level NLR within 1 year
Time frame: 52 weeks
dynamics of level Galectin- 3 within 1 year (ng/ml)
Time frame: 52 weeks
dynamics of level MMP-9 within 1 year (ng/ml)
Time frame: 52 weeks
dynamics of level TIMP - 1 within 1 year (ng/ml)
Time frame: 52 weeks
dynamics of level NGAL within 1 year (ng/ml)
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Dmitry Duplyakov principal investigator
Samara State Medical Universiry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Lipid-lowering Therapy in people with Dyslipidemias, run by Samara Regional Cardiology Dispensary 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Duplyakov, professor (+79277297273, duplyakov@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of change plaque vulnerability parameters on CCTA data (time frame: 52 weeks). 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 18 Nov 2023.