[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06949228":3,"trial-entities:NCT06949228":116,"trial-summary:NCT06949228":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":48,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":87,"locations":90,"central_contacts":100,"overall_officials":109,"references":110,"see_also_links":115},"NCT06949228","ALLY II","Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial","RECRUITING","2028-05-30","2026-01","2026-01-21","2025-07-30","ProMedica Health System","OTHER",true,"The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.",null,[18,19],"Ischemic Stroke","Acute Disease",[21,22,23],"Stroke","TNK","Thrombolytic","INTERVENTIONAL","TREATMENT",[27,28],"PHASE2","PHASE3",{"count":30,"type":31},132,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","tenecteplase","Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.",[38],"Randomized to Intra Arterial (IA) Tenecteplase (TNK)",[40,44],{"measure":41,"description":42,"timeFrame":43},"Primary Efficacy Endpoint- Modified Rankin Scale (mRS)","Proportion of patients with Modified Rankin Scale (mRS) 0-1 at 90-days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).","90 days (+\u002F- 30 days) post treatment.",{"measure":45,"description":46,"timeFrame":47},"Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening","Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS) associated with a Parenchymal hematoma, Type 2 (PH2) brain hemorrhage, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria, within 24 (±12) hours from randomization.","24 hours (+\u002F-12 hours) post treatment.",[49,53,56,60,64,68,72,75],{"measure":50,"description":51,"timeFrame":52},"Ordinal Modified Rankin Scale (mRS)","Ordinal mRS at 90 day. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).","90 days (+\u002F-30 days) post treatment.",{"measure":54,"description":55,"timeFrame":43},"Functional Independence","Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.",{"measure":57,"description":58,"timeFrame":59},"Final Revascularization Grade","Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration.","Immediate post treatment.",{"measure":61,"description":62,"timeFrame":63},"Mortality rate at 90 days","Mortality rate at 90-days","Mortality rate at 90-days (+\u002F- 30 days) post treatment.",{"measure":65,"description":66,"timeFrame":67},"Mortality Rate at discharge","Mortality rate at discharge.","Day 6 (+\u002F-1 day) or Discharge post treatment.",{"measure":69,"description":70,"timeFrame":71},"Infarct Volume Post Procedure","Infarct volume on post-procedure follow-up scans performed at 24 ± 12 hours following mechanical thrombectomy.","24 hours (+\u002F- 12 hours) post treatment.",{"measure":73,"description":74,"timeFrame":71},"Asymptomatic Intracranial hemorrhage","Incidence of any asymptomatic intracranial hemorrhage",{"measure":76,"description":77,"timeFrame":78},"Mean Number of Boluses","Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3 among those without mTICI3 prior to IA-TNK administration.","Immediate post procedure.","ALL","18 Years","85 Years",false,{"inclusion":84,"exclusion":85,"raw_text":86},[],[],"Inclusion Criteria:\n\n1. Age 18-85\n2. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well\n3. Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)\n4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.\n5. Ability to obtain signed informed consent prior to randomization from LAR or Subject\n\nExclusion Criteria:\n\n1. Premorbid modified Rankin scale (mRS) score \\>1\n2. Imaging evidence of hemorrhage or mass effect at baseline\n3. Platelet count \\\u003C100,000\n4. Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency\n5. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \\>1.7\n6. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)\n7. Pregnant or lactating\n8. Previous known allergy to TNK\n9. Major surgery in past 30 days\n10. Patient is on or requires dialysis\n11. History of intracranial hemorrhage or serious head trauma at any time\n12. Any condition in the opinion of the enrolling physician that would preclude the patient from participating\n13. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation\n14. Severe, uncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) that is refractory to treatment\n15. History of acute ischemic stroke in the last 60 days and\u002For has received previous treatment with a thrombolytic within the last 90 days\n16. Presumed septic embolus; suspicion of bacterial endocarditis\n17. Suspicion of aortic dissection\n18. Intracranial neoplasm\n19. Any terminal medical condition with life expectancy less than 6 months\n20. Concurrent enrollment in another trial that could confound the results of this study\n21. Patient is unlikely to return for 90-day follow-up.\n22. Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"status":7,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"ProMedica Toledo Hospital","Toledo","Ohio","43606","United States",{"lat":98,"lon":99},41.66394,-83.55521,[101,106],{"name":102,"role":103,"phone":104,"email":105},"Syed Fazal Zaidi, MD","CONTACT","(419)- 291-8027","Syed.Zaidi2@utoledo.edu",{"name":107,"role":103,"phone":108},"Tanya Siddiqui","4192913498",[],[111],{"pmid":112,"type":113,"citation":114},"39772606","RESULT","Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161\u002FSTROKEAHA.124.048846. Epub 2025 Jan 8.",[],{"nct_id":4,"conditions":117,"biomarkers":118},[18],[],{"nct_id":4,"found":14,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study with a planned enrollment of 132 participants. Patients will be randomly assigned to receive either tenecteplase or a control.","completed","ALLY II Trial: Tenecteplase for Ischemic Stroke After Thrombectomy","This study, called the ALLY II Trial, is looking at whether adding a medicine called tenecteplase directly into an artery (intra-arterial) can help patients who have had a severe type of stroke (ischemic stroke) and have already undergone a procedure to remove a clot (mechanical thrombectomy). Researchers want to see if tenecteplase is safe and effective in improving recovery for patients whose blood flow was largely restored after the initial procedure. You might be able to join if you are 18-85 years old, had a specific type of stroke within 24 hours, and meet certain brain scan criteria after your thrombectomy. The study will measure your recovery at 90 days and check for any safety concerns within 24 hours.","Your recovery will be measured at 90 days after treatment, and safety will be checked at 24 hours after treatment.",119,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]