[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543189":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":101,"centralContacts":114,"locations":123,"responsibleParty":160,"collaborators":162,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":49,"eligibilityCriteria":172,"healthyVolunteers":168,"sex":173,"minAge":174,"maxAge":49,"enrollmentInfo":175,"targetDuration":49,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":126,"whyStopped":49,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"The George Institute","OTHER",[8,16,23,29,37],{"label":9,"type":10,"description":11,"interventionNames":12},"IV thrombolysis domain","EXPERIMENTAL","This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to optimize the use of intravenous Tenecteplase in participants with Acute Ischemic Stroke.",[13,14,15],"Drug: Standard-dose intravenous tenecteplase","Drug: Low-dose intravenous tenecteplase","Other: No intravenous tenecteplase",{"label":17,"type":10,"description":18,"interventionNames":19},"Blood Pressure domain","Third Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED3\u002FMT) as a domain of ACT-GLOBAL to compare three BP lowering management strategies, that of conservative, moderate and intensive BP lowering in patients with Acute Ischaemic Stroke admitted to participating hospitals who has an elevated SBP after reperfusion therapy via Endovascular Thrombectomy, and reliably determine, which approach leads to improved functional outcome.\n\nLocally available and approved i.v. BP lowering agents can be used in this domain.",[20,21,22],"Other: Conservative Blood Pressure Control","Other: Moderate Blood Pressure Control","Other: Intensive Blood Pressure Control",{"label":24,"type":10,"description":25,"interventionNames":26},"ACT-42 domain","This domain has a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive design and aim to determine the efficacy and safety of NoNO-42 in participants with Acute Ischaemic Stroke selected for thrombolysis with or without Endovascular Thrombectomy.",[27,28],"Other: Placebo","Drug: NoNO-42",{"label":30,"type":10,"description":31,"interventionNames":32},"INTERACT5 Domain","This is a domain within the Intracerebral Haemorrhage State of the ACT-GLOBAL adaptive platform trial for stroke.\n\nThe objective of this domain is to determine the efficacy of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, compared to standard of care alone, on improving functional outcome in patients with acute spontaneous supratentorial ICH.",[33,34,35,36],"Other: No deferoxamine mesylate and no colchicine","Drug: Deferoxamine mesylate only","Drug: Colchicine only","Drug: Both deferoxamine mesylate and colchicine",{"label":38,"type":10,"description":39,"interventionNames":40},"IA Thrombolysis Domain","This domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of REACT. This domain aims to efficiently, reliably, and simultaneously, determine the effectiveness of targeted intraarterial (IA) thrombolysis using either tenecteplase or alteplase vs. no IA thrombolysis in all patients who undergo EVT. It has a prospective, randomised, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design of up to 1,500 subjects with AIS who undergo EVT.\n\nRandomisation will be stratified by country\u002F region, and the IA thrombolytic agent (tenecteplase or alteplase). Minimal sufficient balance algorithm will operate within each stratum to preserve balance on key covariates while maintaining allocation randomness.\n\nThe duration of follow-up is 90 days. Primary outcome will be mRS, conducted through centralized telephone interviews or online media performed by central trial personnel blinded treatment assignment and received.",[41,42],"Drug: IA thrombolysis","Other: no IA thrombolysis",[44,50,54,58,62,66,70,74,78,81,85,89,93,97],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Standard-dose intravenous tenecteplase","Standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight); one-time IV bolus injection soon after randomisation",[9],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Low-dose intravenous tenecteplase","Low-dose intravenous tenecteplase (0.18 mg\u002Fkg body weight); one-time IV bolus injection soon after randomisation",[9],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":49},"No intravenous tenecteplase","No intravenous tenecteplase only in subjects on direct oral anticoagulant (DOACs) or those planned for emergency endovascular thrombectomy (EVT)",[9],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":49},"Conservative Blood Pressure Control","No or minimal Systolic Blood Pressure (SBP) control; SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP (≥180mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)",[17],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":49},"Moderate Blood Pressure Control","SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP (150-160mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)",[17],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":49},"Intensive Blood Pressure Control","SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher after endovascular thrombectomy (EVT); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)",[17],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":49},"Placebo","100 mL of 0.9% normal saline, administered as a single IV infusion with a 20-minute dosing duration.",[24],{"type":45,"name":75,"description":76,"armGroupLabels":77,"otherNames":49},"NoNO-42","NoNO-42 at weight-based dosing - 2.6 mg\u002FKg, administered as a single IV infusion with a 20-minute dosing duration",[24],{"type":6,"name":79,"description":79,"armGroupLabels":80,"otherNames":49},"No deferoxamine mesylate and no colchicine",[30],{"type":45,"name":82,"description":83,"armGroupLabels":84,"otherNames":49},"Deferoxamine mesylate only","Deferoxamine mesylate at a dose of 32mg\u002Fkg\u002Fday via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days",[30],{"type":45,"name":86,"description":87,"armGroupLabels":88,"otherNames":49},"Colchicine only","0.5mg of oral colchicine daily for 30 days",[30],{"type":45,"name":90,"description":91,"armGroupLabels":92,"otherNames":49},"Both deferoxamine mesylate and colchicine","Deferoxamine mesylate at a dose of 32mg\u002Fkg\u002Fday via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days",[30],{"type":45,"name":94,"description":95,"armGroupLabels":96,"otherNames":49},"IA thrombolysis","Participants randomised to the IA thrombolysis group will receive IA thrombolysis (tenecteplase or alteplase) at the time of completion of the mechanical thrombectomy part of the EVT procedure. Tenecteplase will be given at a dose of 0.0625mg\u002Fkg (maximum dose of 6.25mg) and alteplase at a dose of 0.225 mg\u002Fkg (maximum dose 22.5mg) intraarterially by the treating neuro-interventional staff. The selection of thrombolytic agent will be determined according to local availability.\n\nThe study drug dose will be increased to 0.125 mg\u002F kg (maximum dose 12.5mg) for tenecteplase or 0.45 mg\u002Fkg (maximum dose 40mg) for alteplase if above dose meet prespecified posterior probabilities at the first or second interims per adaptive design report.",[38],{"type":6,"name":98,"description":99,"armGroupLabels":100,"otherNames":49},"no IA thrombolysis","Participants randomised to the No IA thrombolysis group will not receive IA thrombolysis.",[38],[102,105,108,110,112],{"name":103,"affiliation":5,"role":104},"Craig Anderson, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":106,"affiliation":107,"role":104},"Bijoy Menon, MD","University of Calgary",{"name":109,"affiliation":107,"role":104},"Michael D Hill, MD",{"name":111,"affiliation":107,"role":104},"Andrew Demchuk, MD",{"name":113,"affiliation":5,"role":104},"Xiaoying Chen, PhD",[115,119],{"name":113,"role":116,"phone":117,"phoneExt":49,"email":118},"CONTACT","+61280524549","xchen@georgeinstitute.org.au",{"name":120,"role":116,"phone":121,"phoneExt":49,"email":122},"Bijoy Menon, MD, PhD","+14033381198","docbijoymenon@gmail.com",[124,143],{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"The George Institute for Global Health","RECRUITING","Sydney","New South Wales","2005","Australia","AU",{"type":133,"coordinates":134},"Point",[135,136],151.20732,-33.86785,{"lat":136,"lon":135},[139,141],{"name":113,"role":116,"phone":140,"phoneExt":49,"email":118},"+61 2 8052 4549",{"name":142,"role":116,"phone":49,"phoneExt":49,"email":49},"Craig S Anderson, MD, PhD",{"facility":107,"status":126,"city":144,"state":145,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Calgary","Alberta","T2N 1N4","Canada","CA",{"type":133,"coordinates":150},[151,152],-114.08529,51.05011,{"lat":152,"lon":151},[155,159],{"name":156,"role":116,"phone":157,"phoneExt":49,"email":158},"Carol C Kenney, RN","4039444286","ckenney@ucalgary.ca",{"name":109,"role":116,"phone":49,"phoneExt":49,"email":49},{"type":161,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[163,164],{"name":107,"class":6},{"name":165,"class":6},"Berry Consultants","100543189","phase-3-act-global-adaptive-platform-trial-for-stroke-100543189",false,"NCT06352632","ACT-GLOBAL Adaptive Platform Trial for Stroke","A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)","Platform Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of stroke\n\nPlatform Exclusion Criteria:\n\nThere are no platform level exclusion criteria\n\nEach state and domain will specify additional inclusion and exclusion criteria in the respective Domain-Specific Registration. Patients who fulfill the overall platform criteria will be assessed for enrollment into each active domain.","ALL","18 Years",{"count":176,"type":177},20000,"ESTIMATED","INTERVENTIONAL",[180],"PHASE3","Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment\u002Fs associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options.",[183],"Stroke",[185,186,187,188,189],"Adaptive Platform Trial","Blood Pressure","Tenecteplase","Ischaemic stroke","Intracerebral Haemorrhage","2026-07-06",{"date":192,"type":193},"2026-07-08","ACTUAL",{"date":195,"type":193},"2024-09-26",{"date":197,"type":177},"2034-09",{"name":5,"class":6},2]