[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579239":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":55,"collaborators":24,"id":59,"slug":24,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":24,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":86,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Xijing Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LDL-C target \u003C 0.8 mmol\u002FL","EXPERIMENTAL","After randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range.",[13],"Other: Intensive LDL-C control",{"label":15,"type":16,"description":11,"interventionNames":17},"LDL-C target of 0.8 to 1.4 mmol\u002FL","ACTIVE_COMPARATOR",[18],"Other: Conventional LDL-C control",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Intensive LDL-C control","By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up;\n\nFor patients with baseline LDL-C level \\\u003C 3.0 mmol\u002FL, it is recommended to start lipid control by statin + PCSK9i; for LDL-C level ≥ 3.0 mmol\u002FL, statin + ezetimibe + PCSK9i",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Conventional LDL-C control","By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up;\n\nFor patients with baseline LDL-C level \\\u003C 3.0 mmol\u002FL, it is recommended to start lipid control by statin alone or statin + ezetimibe; for LDL-C level ≥ 3.0 mmol\u002FL, statin + PCSK9i",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Ling Tao, Ph.D., M.D.","Department of Cardiology, Xijing Hospital","STUDY_CHAIR",{"name":35,"affiliation":32,"role":33},"Chao Gao, Ph.D., M.D.",[37],{"name":38,"role":39,"phone":40,"phoneExt":24,"email":41},"Chao Gao, M.D., Ph.D.","CONTACT","86 18629551066","woshigaochao@gmail.com",[43],{"facility":5,"status":24,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":24},"Xi'an","Shannxi","710032","China","CN",{"type":50,"coordinates":51},"Point",[52,53],108.92861,34.25833,{"lat":53,"lon":52},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Ling Tao, MD, PhD","Professor in Cardiology, Director of the Department of Cardiology","100579239",false,"NCT06821711","Optimal LDL-C Target in High-risk Patients After PCI","Targeting LDL-C to Less Than 0.8 mmol\u002FL in Patients After PCI With High Risk of Cardiovascular Disease: an Open-label, Assessor-blinded, Randomized Trial (REC-SAFETARGET Trial)","REC-SAFETARGET","Inclusion Criteria:\n\n1. Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome\n2. Patients with ASCVD at extremely high risk\n3. Patients who are able to complete the follow-up and compliant with the allocated treatment\n\n   * ASCVD at extremely high risk is defined as fulfilling at least TWO of the following criteria:\n\n     1. PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)\n     2. Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease\n     3. Experienced cardiovascular event(s) with LDL-C≤1.8mmol\u002FL\n     4. LDL-C≥4.9mmol\u002FL\n     5. Diabetes\n     6. CKD (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2)\n     7. Current smoking\n     8. Recurrent cardio\u002Fcerebrovascular events\n     9. History of premature ASCVD (\\\u003C 55 male, \\\u003C 65 female)\n     10. Complex PCI (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion))\n\nExclusion Criteria:\n\n1. Age less than 18 years;\n2. Unable to give informed consent or currently participating in other trials;\n3. Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;\n4. Concurrent medical condition with a life expectancy of less than 3 years;\n5. Hemodynamic unstable;\n6. Active liver disease or hepatic dysfunction (persistent unexplained ALT\u002FAST elevations (≥ 3 × ULN)), patients with a transient increase ALT\u002FAST due to the acute MI may be enrolled;\n7. Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications;\n8. LDL-C ≤ 1.4 mmol\u002FL at baseline without any lipid control medication lowering LDL-C;\n9. Known active infection or critical hematologic\u002Fendocrine dysfunction.","ALL","18 Years",{"count":69,"type":70},12000,"ESTIMATED","INTERVENTIONAL",[73],"NA","Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.\n\nLipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to \\\u003C1.4 mmol\u002FL with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.\n\nAgainst these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels \\\u003C0.8 mmol\u002FL in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol\u002FL.",[76,77,78,79],"Chronic Coronary Syndrome","Acute Coronary Syndromes","Percutaneous Coronary Intervention","High Risk Patient",[81,82,83,84,85],"Acute coronary syndrome","Chronic coronary syndrome","Percutaneous coronary intervention","LDL-C","lipid","NOT_YET_RECRUITING","2025-02-17",{"date":89,"type":90},"2025-02-19","ACTUAL",{"date":92,"type":70},"2025-02-20",{"date":94,"type":70},"2029-08-15",{"name":5,"class":6},1]