Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2019
INTERVENTION: Patients in the alirocumab arm will receive subcutaneous alirocumab 75 mg every 2 weeks (Q2W) in addition to statin therapy (rosuvastatin 10 mg/day). Patients in the standard‐of‐care arm will receive rosuvastatin 10 mg/day, with initiation and/or dose adjustment of non‐statin lipid‐lowering drugs to achieve an LDL‐C target <70 mg/dL CONDITION: coronary artery disease PRIMARY OUTCOME: the change in minimum fibrous‐cap thickness between baseline and the 36‐week follow‐up SECONDARY OUTCOME: 1: the absolute change in lipid length; 2: the percentage change in lipid length; 3: the absolute change in max lipid arc; 4: the percentage change in max lipid arc; 5: the absolute change in mean lipid arc; 6: the percentage change in mean lipid arc ; 7: the absolute change in lipid index; 8: the percentage change in lipid index; 9: the absolute change in macrophage grade; 10: the percentage change in macrophage grade ; 11: he absolute change in minimum lumen area; 12: the percentage change in minimum lumen area; 13: the absolute change in fibrous cap thickness; 14: the percentage number of thin‐cap fibroatheroma ; 15: the absolute change in LDL‐C ; 16: the percentage change in LDL‐C ; 17: the absolute change in HDL‐C ; 18: the percentage change in HDL‐C ; 19: the absolute change in non‐HDL‐C ; 20: the percentage change in non‐HDL‐C ; 21: the absolute change in apolipoprotein B ; 22: the percentage change in apolipoprotein B ; 23: the absolute change in triglyceride; 24: the percentage change in triglyceride; 25: the absolute change in Lp (a); 26: the percentage change in Lp (a) ; 27: the absolute change in hs‐CRP ; 28: the percentage change in hs‐CRP; 29: the absolute change in IL‐1 beta; 30: the percentage change in IL‐1 beta; 31: the absolute change in IL‐6 ; 32: the percentage change in IL‐6; 33: the absolute change in TNF‐alpha; 34: the percentage change in TNF‐alpha; 35: the absolute change in MCP‐1 ; 36: the percentage change in MCP‐1; 37: the absolute change in VCAM‐1 ; 38: the percentage change in VCAM‐1 ; 39: the absolute change in ICAM‐1 ; 40: the percentage change in ICAM‐1 ; 41: the absolute change in MMP‐2 ; 42: the percentage change in MMP‐2 ; 43: the absolute change in MMP‐9 ; 44: the percentage change in MMP‐9 ; 45: the absolute change in free PCSK9 ; 46: the percentage change in free PCSK9 INCLUSION CRITERIA: ALTAIR employs the following eligibility criteria: 1: Patients who underwent PCI for ACS or stable coronary heart disease ACS is defined as ST‐segment elevation myocardial infarction (STEMI), non‐ST‐segment elevation myocardial infarction (NSTEMI), or unstable angina. STEMI is defined as symptoms suggesting ischemia (e.g., chest pain or shortness of breath), with more than or equal 1 mm of ST elevation in more than or equal 2 consecutive chest leads or in more than or equal 2 consecutive limb leads on electrocardiography or with a new left bundle branch block, and with elevated cardiac marker levels (cardiac troponin I levels above the 99th percentile upper reference limit). NSTEMI is defined as symptoms suggesting ischemia, with ST depression more than 0.5 mm (0.05 mV), negative T‐wave (more than or equal 0.1 mV), or transient ST elevation less than or equal 0.5 mm, and with elevated cardiac marker levels (as described for STEMI). Unstable angina is defined a
Epistemonikos ID: 2b194923817cc563896065bb35f6a2f70e1355bb
First added on: Aug 24, 2024