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| Name | Class |
|---|---|
| Samara State Medical University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Lipid-lowering Therapy | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Total cholesterol, LDL-C, HDL-C, triglycerides levels after 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Duplyakov, professor | Contact | +79277297273 | duplyakov@yahoo.com | |
| Anna Kovalskaya | Contact | +79270130848 | kovalskaya.an@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dmitry Duplyakov | Samara State Medical Universiry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samara Regional Cardiology Dispansery | Recruiting | Samara | 443070 | Russia |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
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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).
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blood sampling at control visits every 3 months |
| 52 weeks |
| dynamics of level hs-Troponin I within 1 year (ng/l) | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level hs-CRP within 1 year (mg/l) | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level NLR within 1 year | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level Galectin- 3 within 1 year (ng/ml) | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level MMP-9 within 1 year (ng/ml) | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level TIMP - 1 within 1 year (ng/ml) | blood sampling at the second visit and 12 months later | 52 weeks |
| dynamics of level NGAL within 1 year (ng/ml) | blood sampling at the second visit and 12 months later | 52 weeks |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |