[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522325":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":55,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":25,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Evolocumab","EXPERIMENTAL","Evolocumab is the drug that will be administered in this study. It will be administered as a 140mg subcutaneous injection every 14 days for 5 weeks (for a total of 3 doses).",[13],"Drug: Evolocumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This arm is a matching placebo that will be administered in the same fashion as the study drug if the patient is randomized to placebo.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","See arm description.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Scott Damrauer, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":25,"email":36},"CONTACT","215-615-1698","damrauer@upenn.edu",[38],{"facility":39,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19010","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-75.16362,39.95238,{"lat":49,"lon":48},[52],{"name":30,"role":34,"phone":53,"phoneExt":25,"email":54},"215-6140176","scott.damrauer@pennmedicine.upenn.edu",{"type":31,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Scott Damrauer","Associate Professor of Surgery",[59,62],{"name":60,"class":61},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":63,"class":64},"Amgen","INDUSTRY","100522325","early-phase-1-mechanistic-clinical-trial-of-pcsk9-inhibition-for-aaa-100522325",false,"NCT06081153","Mechanistic Clinical Trial of PCSK9 Inhibition for AAA","A Randomized, Placebo-Controlled Mechanistic Clinical Trial of PCSK9 Inhibition With Evolocumab in Patients Undergoing Open Abdominal Aortic Aneurysm Repair","Inclusion Criteria:\n\n1. Abdominal aortic aneurysm (AAA) requiring open surgical repair\n2. Age \\> 18\n3. Provision of signed and dated informed consent form\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n1. Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit\n2. LDL-C \\\u003C 40 mg\u002FdL (within 3 months of baseline visit)\n3. Known allergy to PCSK9 inhibitor\n4. Aortic dissection\n5. Vascular connective tissue disorders\n6. Type I-III or V Thoraco-abdominal Aortic Aneurysm\n7. Vasculitis or inflammatory aneurysm\n8. Pregnant or lactating women\n9. Poorly controlled diabetes (A1C \\> 10%)\n10. Chronic kidney disease Stage 4\u002F5 or End Stage Renal Disease (ESRD) on hemodialysis (HD)\n11. Liver Disease (alanine transaminase \\[ALT\\] or aspartate aminotransferase \\[ALT\\] \\> 3.0 x upper limits of normal) (within 3 months of baseline visit)\n12. Known latex or naturally rubber allergy\n13. Treatment with another investigational product within 30 days or 5 half-lives of the investigation drug before consent (whichever is longer) that would have an impact on endpoints associated with this trial.\n14. Any other condition that the Investigator feels prohibits participants' ability to comply with study or follow up.","ALL","18 Years",{"count":75,"type":76},44,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.",[82],"Abdominal Aortic Aneurysm","NOT_YET_RECRUITING","2026-04-16",{"date":86,"type":87},"2026-04-20","ACTUAL",{"date":89,"type":76},"2026-12-01",{"date":91,"type":76},"2029-02-28",{"name":5,"class":6},1]