Left main coronary artery disease
Conditions
Interventions
Intensive statin therapy group:intensive statin therapy
The control group:Standard dose statin therapy
Sponsors
Wuhan Asia Heart Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 20 to 75 years old; 2.Patients with left main stem disease or left main stem disease plus 1-3 vessel disease, and left main stem disease requiring revascularization treatment (left main stem disease refers to any part of the left main stem opening, body, or distal end lesion), and SYNTAX score less than 33 are willing to undergo elective IVUS-guided PCI treatment. 3.The subject or (legal representative) must provide a personally signed and dated informed consent indicating that the subject or legal representative has been informed of all relevant aspects of the trial.
Exclusion criteria
Exclusion criteria: 1.Patients with acute STEMI or high-risk non-ST elevation acute coronary syndrome need emergency PCI; 2.Myocardial enzymes did not decrease to normal after acute STEMI or heart failure was not effectively controlled; 3.Patients were taking statins (for more than 1 week) or, as determined by the investigator, required long-term use of statins in excess of atorvastatin 20mg or simvastatin 20mg, pravastatin 40mg, fluvastatin 80mg, rosuvastatin 10mg, lovastatin 40mg, etc., or required concomitant use of bate lipid-regulating drugs. 4.Repeat PCI was planned within 6 months. 5.Patients who had not taken statins in the last 1 month had LDL-C < 1.81mmol/L before enrollment; 6.Patients with end-stage chronic congestive heart failure or LVEF < 30%; 7.Active liver disease or liver insufficiency, or elevated AST and ALT, greater than 1.5 times the upper limit of normal reference values; 8.myopathy or elevated muscle enzymes (creatine kinase (CK) greater than 2 times the normal reference value upper limit); 9.severe renal insufficiency (eGFR <30 ml/min); 10.Patients who are allergic to statins or contrast agents; 11.Lab tests showed that white blood cells (WBC) <4×10?9/L or platelet (PLT)<100×10?9/L; 12.combined with other serious heart diseases, such as severe aortic stenosis or mitral stenosis, hypertrophic obstructive cardiomyopathy, infective endocarditis or pericardial disease, etc; 13.Patients who were pregnant and breastfeeding. 14.combined with malignant tumors or other diseases resulting in a life expectancy of less than 6 months; 15.Participating in other clinical studies; 16.Other conditions considered by the investigator to be ineligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major cardiovascular events (the combined endpoint of cardiac death, myocardial infarction, and target revascularization) at 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of hs-CRP at 24 hours after operation compared with pre-operation;Proportion of patients with AST or ALT > 3 times the upper limit of normal reference value or CK > 5 times the upper limit of normal reference value in any postoperative assay. The proportion of AST, ALT, or CK above the upper limit of normal reference values in any postoperative;Proportion of patients with atorvastatin reduction, discontinuation, or withdrawal from the study due to adverse events.;The changes of Scr, eGFR, cystatin C and urinary microalbumin 24 hours, 30 days and 6 months after operation were compared with those before operation;The composite endpoint was death, cardiac death, myocardial infarction, heart failure, hospitalization for cardiac causes, and repeat target vessel revascularization at 6 months after the intervention.;The composite endpoint was death, cardiac death, myocardial infarction, heart failure, hospitalization for cardiac causes, and repeat target vessel revascularization at 12 and 24 months.; | — |
Countries
China
Contacts
Public ContactHua Yan
Wuhan Asia Heart Hospital
Outcome results
None listed