[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Middle East North Africa Stroke and Interventional Neurotherapies Organization\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":21,"type":22},280,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Carotid Stenosis",[30,31,32],"vulnerable plaque","alirocumab","PCSK9 inhibitor","NOT_YET_RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":22},"2027-07",{"date":41,"type":22},"2030-09",{"name":43,"class":44},"Middle East North Africa Stroke and Interventional Neurotherapies Organization","OTHER",14,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100635104","mena-regional-endovascular-intervention-for-venous-cerebral-venous-sinus-thrombosis-100635104","NCT07548346","MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis","REVIVE-CVST: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint (PROBE) Trial of Endovascular Thrombectomy Plus Standard Medical Care Versus Standard Medical Care Alone in Adults With Acute or Subacute Cerebral Venous Sinus Thrombosis at High Risk of Poor Outcome in the Middle East and North Africa Region","REVIVE-CVST","Inclusion Criteria:\n\n* Age 18-65 years, inclusive\n* Radiologically confirmed cerebral venous sinus thrombosis (CVST) by CT venography (CTV), MR venography (MRV), or digital subtraction angiography (DSA), with thrombosis of at least one major dural sinus\n* Acute or subacute presentation with symptom onset within 21 days of randomization\n* MRI phase characterization confirming acute or subacute phase\n* At least one risk factor for poor outcome: symptoms of intracranial hypertension (severe headache, papilledema, visual obscurations), focal neurological deficit, seizures, altered consciousness (GCS 9-14), intracranial hemorrhage from venous congestion, or deep venous system thrombosis\n* Significant venous outflow obstruction on imaging\n* Written informed consent from patient or legally authorized representative\n\nExclusion Criteria:\n\n* Isolated cortical vein thrombosis without dural sinus involvement\n* Isolated cavernous sinus thrombosis\n* Chronic-phase CVST on MRI phase characterization\n* Pre-morbid modified Rankin Scale (mRS) score greater than 2\n* Glasgow Coma Scale (GCS) score less than 9 at randomization\n* Imminent risk of transtentorial herniation requiring emergent decompressive craniectomy\n* Massive cerebral edema with midline shift greater than 10 mm requiring surgical intervention\n* Active systemic bleeding or hemorrhagic diathesis\n* Severe allergy to iodinated contrast media\n* CVST secondary to active hematological malignancy or life expectancy less than 12 months\n* Pregnancy\n* Participation in another interventional clinical trial within 30 days\n* Any condition rendering the patient unsuitable for study participation per investigator judgment","18 Years","65 Years",{"count":57,"type":22},440,[59],"NA","REVIVE-CVST is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial evaluating whether early endovascular thrombectomy (EVT) combined with standard anticoagulation improves outcomes compared to anticoagulation alone in patients with severe cerebral venous sinus thrombosis (CVST).\n\nThe study targets adult patients (aged 18 years or older) presenting within 14 days of symptom onset with imaging-confirmed CVST and at least one severity marker, such as a Glasgow Coma Scale score of 14 or below, intracerebral hemorrhage, venous infarction, or deep venous system involvement.\n\nParticipants will be randomly assigned in a 1:1 ratio to either the intervention arm (EVT plus anticoagulation) or the control arm (anticoagulation alone). The primary endpoint is functional outcome at 180 days as measured by the modified Rankin Scale (mRS), using a shift analysis across all mRS categories.\n\nThe trial aims to enroll 440 participants across approximately 15 centers in the Middle East, North Africa, South Asia, and Turkey (MENA-SINO network). The study duration is approximately 42 months, including 18 months of enrollment and 12 months of follow-up for the last enrolled patient.",[62],"Cerebral Venous Sinus Thrombosis",[64,65,66],"CVST","endovascular thrombectomy","anticoagulation","2026-04-16",{"date":69,"type":37},"2026-04-23",{"date":71,"type":22},"2026-07",{"date":73,"type":22},"2030-01",{"name":43,"class":44},""]