Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05624658
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-11-08
Brief Title:
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
Sponsor:
Samara Regional Cardiology Dispensary
Organization:
Samara Regional Cardiology Dispensary
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Combi-LLT ACS
Brief 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 14 mmoll 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None