[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638609":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":36,"responsibleParty":159,"collaborators":27,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":166,"sex":172,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":27,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":188,"whyStopped":27,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Middle East North Africa Stroke and Interventional Neurotherapies Organization","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Alirocumab + High-Intensity Statin","EXPERIMENTAL","Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen, self-administered or caregiver-administered, from randomisation through week 52. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.",[13,14,15],"Drug: Alirocumab","Drug: Placebo","Drug: Atorvastatin",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo + High-Intensity Statin","PLACEBO_COMPARATOR","Matched placebo subcutaneous injection every 2 weeks via pre-filled pen from randomisation through week 52, visually identical to alirocumab. Plus atorvastatin 80 mg daily (or rosuvastatin 40 mg if intolerant) as background therapy.",[13,14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Alirocumab","Alirocumab 150 mg subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses. Alirocumab is a fully human monoclonal antibody that inhibits PCSK9, leading to significant LDL-C reduction beyond that achieved with statins alone.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo","Matched placebo subcutaneous injection every 2 weeks via pre-filled pen for 52 weeks. Visually identical to alirocumab injection. First dose given at randomisation visit under supervision. Self-administered or caregiver-administered at home for subsequent doses.",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Atorvastatin","Atorvastatin 80 mg oral tablet once daily as background high-intensity statin therapy for both arms. Rosuvastatin 40 mg daily may be substituted if patient is intolerant to atorvastatin. Administered throughout the entire study duration (52 weeks).",[9,17],[37,48,56,61,66,76,86,96,106,116,124,132,142,151],{"facility":38,"status":27,"city":39,"state":27,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":27},"Alexandria University, Smouha University Comprehensive Stroke Center","Alexandria","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],29.91582,31.20176,{"lat":46,"lon":45},{"facility":49,"status":27,"city":50,"state":27,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":51,"geoPoint":55,"contacts":27},"Ain Shams University","Cairo",{"type":43,"coordinates":52},[53,54],31.24967,30.06263,{"lat":54,"lon":53},{"facility":57,"status":27,"city":50,"state":27,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":60,"contacts":27},"Cairo University",{"type":43,"coordinates":59},[53,54],{"lat":54,"lon":53},{"facility":62,"status":27,"city":50,"state":27,"zip":27,"country":40,"countryCode":41,"cosmosGeoPoint":63,"geoPoint":65,"contacts":27},"Neurology Department, Al-Azhar University",{"type":43,"coordinates":64},[53,54],{"lat":54,"lon":53},{"facility":67,"status":27,"city":68,"state":27,"zip":27,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":27},"Amman Specialized IR Center","Amman","Jordan","JO",{"type":43,"coordinates":72},[73,74],35.94503,31.95522,{"lat":74,"lon":73},{"facility":77,"status":27,"city":78,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":27},"Centre Hospitalier Universitaire Ibn Sina de Rabat","Rabat","Morocco","MA",{"type":43,"coordinates":82},[83,84],-6.83255,34.01325,{"lat":84,"lon":83},{"facility":87,"status":27,"city":88,"state":27,"zip":27,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":27},"Aga Khan University","Karachi","Pakistan","PK",{"type":43,"coordinates":92},[93,94],67.0104,24.8608,{"lat":94,"lon":93},{"facility":97,"status":27,"city":98,"state":27,"zip":27,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":27},"Weill Cornell Medicine-Qatar","Doha","Qatar","QA",{"type":43,"coordinates":102},[103,104],51.53096,25.28545,{"lat":104,"lon":103},{"facility":107,"status":27,"city":108,"state":27,"zip":27,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":27},"King Khalid University","Abhā","Saudi Arabia","SA",{"type":43,"coordinates":112},[113,114],42.50528,18.21639,{"lat":114,"lon":113},{"facility":117,"status":27,"city":118,"state":27,"zip":27,"country":109,"countryCode":110,"cosmosGeoPoint":119,"geoPoint":123,"contacts":27},"King Abdulaziz Medical City","Jeddah",{"type":43,"coordinates":120},[121,122],39.18624,21.49012,{"lat":122,"lon":121},{"facility":125,"status":27,"city":126,"state":27,"zip":27,"country":109,"countryCode":110,"cosmosGeoPoint":127,"geoPoint":131,"contacts":27},"King Abdullah Medical City","Mecca",{"type":43,"coordinates":128},[129,130],39.82563,21.42664,{"lat":130,"lon":129},{"facility":133,"status":27,"city":134,"state":27,"zip":27,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":27},"Institut National de Neurologie","Tunis","Tunisia","TN",{"type":43,"coordinates":138},[139,140],10.16579,36.81897,{"lat":140,"lon":139},{"facility":143,"status":27,"city":144,"state":27,"zip":27,"country":145,"countryCode":27,"cosmosGeoPoint":146,"geoPoint":150,"contacts":27},"Department of Neurology, Eskisehir Osmangazi University","Eskişehir","Turkey (Türkiye)",{"type":43,"coordinates":147},[148,149],30.52056,39.77667,{"lat":149,"lon":148},{"facility":152,"status":27,"city":153,"state":27,"zip":27,"country":145,"countryCode":27,"cosmosGeoPoint":154,"geoPoint":158,"contacts":27},"Neurology Department, Dr. Lutfi Kirdar City Hospital","Istanbul",{"type":43,"coordinates":155},[156,157],28.94966,41.01384,{"lat":157,"lon":156},{"type":160,"investigatorFullName":161,"investigatorTitle":162,"investigatorAffiliation":163,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Ossama Mansour","Professor of Neurology, Alexandria University","Alexandria University","100638609","phase-3-alirocumab-for-stabilisation-of-symptomatic-vulnerable-carotid-plaque-100638609",false,"NCT07586540","Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque","Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial With High-Resolution Vessel-Wall MRI and Clinical Endpoints","CAROTID-STABIL","Inclusion Criteria:\n\n1. Age ≥ 40 and ≤ 80 years\n2. Recently symptomatic (TIA, amaurosis fugax, or non-disabling ischaemic stroke with mRS ≤ 2) referable to a carotid territory within 28 days of randomisation\n3. Ipsilateral extracranial internal carotid artery stenosis of 50-69% by NASCET criteria on CTA or DSA\n4. HR-VW-MRI evidence of IPH (MPRAGE hyperintensity ≥150% of adjacent sternocleidomastoid) OR LRNC ≥ 10% of plaque volume in the symptomatic plaque\n5. On a stable dose of high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for ≥ 4 weeks, or able and willing to initiate atorvastatin 80 mg daily at randomisation\n6. LDL-C ≥ 70 mg\u002FdL (1.8 mmol\u002FL) at screening\n7. Able to undergo 3T MRI (no contraindications)\n8. Provides written informed consent\n\nExclusion Criteria:\n\n1. Indication for urgent carotid revascularisation within 14 days per treating team\n2. Disabling stroke (mRS \\> 2) or NIHSS \\> 5 at randomisation\n3. Carotid stenosis ≥ 70% or occlusion\n4. Cardioembolic stroke source (atrial fibrillation, LV thrombus, endocarditis, PFO with high-risk features)\n5. Intracranial haemorrhage within 12 months or any history of symptomatic ICH\n6. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n7. Active hepatobiliary disease or ALT\u002FAST \\> 3x ULN\n8. Prior exposure to any PCSK9 inhibitor or inclisiran within 6 months\n9. Known hypersensitivity to alirocumab or excipients\n10. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential\n11. Life expectancy \\\u003C 24 months\n12. Participation in another interventional trial within 30 days\n13. Inability to comply with follow-up or MRI schedule","ALL","40 Years","80 Years",{"count":176,"type":177},280,"ESTIMATED","INTERVENTIONAL",[180],"PHASE3","CAROTID-STABILISE is a phase III, multicentre, randomised, double-blind, placebo-controlled trial evaluating whether alirocumab 150 mg subcutaneously every 2 weeks, added to high-intensity statin therapy, produces greater reduction in intraplaque haemorrhage (IPH) volume at 26 weeks compared with placebo in patients with recently symptomatic carotid stenosis of 50-69% harbouring IPH or lipid-rich necrotic core (LRNC) on high-resolution vessel-wall MRI. The study will enroll 280 participants across multiple centres with a 52-week extension for durability and clinical endpoints assessment.",[183],"Carotid Stenosis",[185,186,187],"vulnerable plaque","alirocumab","PCSK9 inhibitor","NOT_YET_RECRUITING","2026-05-08",{"date":191,"type":192},"2026-05-14","ACTUAL",{"date":194,"type":177},"2027-07",{"date":196,"type":177},"2030-09",{"name":5,"class":6},14]