[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540714":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":32,"centralContacts":39,"locations":46,"responsibleParty":387,"collaborators":390,"id":393,"slug":394,"hasResults":395,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":395,"sex":401,"minAge":402,"maxAge":12,"enrollmentInfo":403,"targetDuration":12,"studyType":406,"phases":407,"briefSummary":409,"conditions":410,"keywords":414,"overallStatus":68,"whyStopped":12,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight)","NO_INTERVENTION","The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.25 mg\u002Fkg body weight (maximum dose 25 mg) over 10-20 seconds as soon as possible after randomization.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"2) IVT with tenecteplase at low-dose: 0.18 mg\u002Fkg","ACTIVE_COMPARATOR","The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.18 mg\u002Fkg body weight (maximum dose 18 mg) over 10-20 seconds as soon as possible after randomization.",[18],"Drug: Tenecteplase",{"label":20,"type":15,"description":21,"interventionNames":22},"3) No IV thrombolysis [(only in those undergoing EVT or those on DOACs)","No intravenous tenecteplase only applied to subjects on DOACs over the last 24 hours or those planned for emergency EVT",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Tenecteplase","Thrombolytic",[14,20],[30,31],"TNKase","Metalyse",[33,36],{"name":34,"affiliation":5,"role":35},"Bijoy K Menon, MD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Craig Anderson, MD","The George 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Hospital","RECRUITING","New South Wales",{"type":56,"coordinates":71},[58,59],{"lat":59,"lon":58},[74],{"name":75,"role":35,"phone":12,"phoneExt":12,"email":12},"Timothy Ang, MD",{"facility":77,"status":68,"city":78,"state":79,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Monash University (Box Hill)","Melbourne","Victoria",{"type":56,"coordinates":81},[82,83],144.96332,-37.814,{"lat":83,"lon":82},[86,89],{"name":87,"role":41,"phone":12,"phoneExt":12,"email":88},"Tessa Busch","tessa.busch@monash.edu",{"name":90,"role":35,"phone":12,"phoneExt":12,"email":12},"Philip Choi, MD",{"facility":5,"status":68,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Calgary","Alberta","T2N 1N4","Canada","CA",{"type":56,"coordinates":98},[99,100],-114.08529,51.05011,{"lat":100,"lon":99},[103,107,110],{"name":104,"role":41,"phone":105,"phoneExt":12,"email":106},"Carol C Kenney, 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Deer",{"type":56,"coordinates":129},[130,131],-113.802,52.26682,{"lat":131,"lon":130},[134,137],{"name":135,"role":41,"phone":12,"phoneExt":12,"email":136},"Elaine Shand, RN","BElaine.Shand@albertahealthservices.ca",{"name":138,"role":35,"phone":12,"phoneExt":12,"email":12},"Oje Imoukheude, MD",{"facility":140,"status":68,"city":141,"state":142,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Alberta","Edmonton","A",{"type":56,"coordinates":144},[145,146],-113.46871,53.55014,{"lat":146,"lon":145},[149,152,155],{"name":150,"role":41,"phone":12,"phoneExt":12,"email":151},"Paige Fairall","fairall@ualberta.ca",{"name":153,"role":41,"phone":12,"phoneExt":12,"email":154},"Emily Sugars","esugars@ualberta.ca",{"name":156,"role":35,"phone":12,"phoneExt":12,"email":12},"Brian Buck, MD",{"facility":158,"status":49,"city":159,"state":160,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Kelowna Regional Hospital","Kelowna","British Columbia",{"type":56,"coordinates":162},[163,164],-119.48568,49.88307,{"lat":164,"lon":163},[167],{"name":168,"role":35,"phone":12,"phoneExt":12,"email":12},"Aleksander Tkach, MD",{"facility":170,"status":49,"city":171,"state":160,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Royal Columbian Hospital","New Westminster",{"type":56,"coordinates":173},[174,175],-122.91092,49.20678,{"lat":175,"lon":174},[178,180],{"name":179,"role":41,"phone":12,"phoneExt":12,"email":12},"Vishaya Naidoo",{"name":181,"role":35,"phone":12,"phoneExt":12,"email":12},"George Medvedev, MD",{"facility":183,"status":68,"city":184,"state":160,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University of British Columbia","Vancouver",{"type":56,"coordinates":186},[187,188],-123.11934,49.24966,{"lat":188,"lon":187},[191,194,197],{"name":192,"role":41,"phone":12,"phoneExt":12,"email":193},"Geni Maclean, RN,","genoveva@bcstrokecentre.ca",{"name":195,"role":41,"phone":12,"phoneExt":12,"email":196},"Carson Ma, RN,","carson.ma@vch.ca",{"name":198,"role":35,"phone":12,"phoneExt":12,"email":12},"Thalia S Field, MD",{"facility":200,"status":49,"city":201,"state":202,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Brandon Regional Hospital","Brandon","Manitoba",{"type":56,"coordinates":204},[205,206],-99.95306,49.84692,{"lat":206,"lon":205},[209,212],{"name":210,"role":41,"phone":12,"phoneExt":12,"email":211},"Leanne Anderson","LAnderson2@pmh-mb.ca",{"name":213,"role":35,"phone":12,"phoneExt":12,"email":12},"Arturo Tamayo Tamayo, MD",{"facility":215,"status":68,"city":216,"state":202,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"University of Manitoba - Winnipeg Health Science Centre","Winnipeg",{"type":56,"coordinates":218},[219,220],-97.14704,49.8844,{"lat":220,"lon":219},[223,226],{"name":224,"role":41,"phone":12,"phoneExt":12,"email":225},"Nishita Singh, Dr.","nishita.singh@umanitoba.ca",{"name":227,"role":35,"phone":12,"phoneExt":12,"email":12},"Nishita Singh, MD",{"facility":229,"status":49,"city":230,"state":231,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Queen Elizabeth II Health Science Center (Halifax)","Halifax","Nova Scotia",{"type":56,"coordinates":233},[234,235],-63.57688,44.64269,{"lat":235,"lon":234},[238],{"name":239,"role":35,"phone":12,"phoneExt":12,"email":12},"Sherry Hu, MD",{"facility":241,"status":68,"city":242,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Health Sciences North Horizon Sante-Nord","Greater Sudbury","Ontario",{"type":56,"coordinates":245},[246,247],-80.99001,46.49,{"lat":247,"lon":246},[250,253],{"name":251,"role":41,"phone":12,"phoneExt":12,"email":252},"Mythili Velma","mvelma@hsnri.ca",{"name":254,"role":35,"phone":12,"phoneExt":12,"email":12},"Ravinder Singh, MD",{"facility":256,"status":68,"city":257,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"McMaster University Hamilton Health Sciences Centre","Hamilton",{"type":56,"coordinates":259},[260,261],-79.84963,43.25011,{"lat":261,"lon":260},[264,267],{"name":265,"role":41,"phone":12,"phoneExt":12,"email":266},"Kanchana Ratnayake","ratnayake@hhsc.ca",{"name":268,"role":35,"phone":12,"phoneExt":12,"email":12},"Lucianna Catanese, MD",{"facility":270,"status":49,"city":271,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Kingston General Hospital","Kingston",{"type":56,"coordinates":273},[274,275],-76.48098,44.22976,{"lat":275,"lon":274},[278],{"name":279,"role":35,"phone":12,"phoneExt":12,"email":12},"Shirin Jalini, MD",{"facility":281,"status":49,"city":282,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Lawson Health Research Institute- London","London",{"type":56,"coordinates":284},[285,286],-81.23304,42.98339,{"lat":286,"lon":285},[289,292,294],{"name":290,"role":41,"phone":12,"phoneExt":12,"email":291},"Beth Beauchamp, RN","Beth.Beauchamp@lhsc.on.ca",{"name":293,"role":41,"phone":12,"phoneExt":12,"email":12},"Lindsay Lindsay.Lambourn@lhsc.on.ca, RN",{"name":295,"role":35,"phone":12,"phoneExt":12,"email":12},"Jennifer Mandzia, MD",{"facility":297,"status":68,"city":298,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"University of Ottawa","Ottawa",{"type":56,"coordinates":300},[301,302],-75.69812,45.41117,{"lat":302,"lon":301},[305,308],{"name":306,"role":41,"phone":12,"phoneExt":12,"email":307},"Brian Dewar, MS","bdewar@ohri.ca",{"name":309,"role":35,"phone":12,"phoneExt":12,"email":12},"Michel Shamy, MD",{"facility":311,"status":68,"city":312,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"St. Michael's Hospital","Toronto",{"type":56,"coordinates":314},[315,316],-79.39864,43.70643,{"lat":316,"lon":315},[319,322],{"name":320,"role":41,"phone":12,"phoneExt":12,"email":321},"Pawell Kostyrko","pawel.kostyrko@unityhealth.to",{"name":323,"role":35,"phone":12,"phoneExt":12,"email":12},"Alexandra Muccilli, MD",{"facility":325,"status":68,"city":312,"state":243,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":326,"geoPoint":328,"contacts":329},"Sunnybrook Health Science Centre",{"type":56,"coordinates":327},[315,316],{"lat":316,"lon":315},[330,333],{"name":331,"role":41,"phone":12,"phoneExt":12,"email":332},"Richard Swartz, MD","rick.swartz@sunnybrook.ca",{"name":331,"role":35,"phone":12,"phoneExt":12,"email":12},{"facility":335,"status":68,"city":336,"state":337,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"Queen Elizabeth Hospital (PEI)","Charlottetown","Prince Edward Island",{"type":56,"coordinates":339},[340,341],-63.1256,46.23459,{"lat":341,"lon":340},[344],{"name":345,"role":35,"phone":12,"phoneExt":12,"email":12},"Heather Williams, MD",{"facility":347,"status":49,"city":348,"state":349,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":350,"geoPoint":354,"contacts":355},"Centre Hospitalier de l'Université de Montréal (CHUM)","Montreal","Quebec",{"type":56,"coordinates":351},[352,353],-73.58781,45.50884,{"lat":353,"lon":352},[356],{"name":357,"role":35,"phone":12,"phoneExt":12,"email":12},"Alex Poppe, MD",{"facility":359,"status":49,"city":360,"state":349,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"CIUSSS de l'Estrie - CHUS Fleurimont Hôpital (Sherbrooke)","Sherbrooke",{"type":56,"coordinates":362},[363,364],-71.89908,45.40008,{"lat":364,"lon":363},[367,370],{"name":368,"role":41,"phone":12,"phoneExt":12,"email":369},"Caroline Cayer, RN","caroline.cayer.ciussse-chus@ssss.gouv.qc.ca",{"name":371,"role":35,"phone":12,"phoneExt":12,"email":12},"Francois Moreau, MD",{"facility":373,"status":68,"city":374,"state":375,"zip":12,"country":95,"countryCode":96,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"Royal University Hospital","Saskatoon","Saskatchewan",{"type":56,"coordinates":377},[378,379],-106.66892,52.13238,{"lat":379,"lon":378},[382,385],{"name":383,"role":41,"phone":12,"phoneExt":12,"email":384},"Cassandra Tyson","cat382@mail.usask.ca",{"name":386,"role":35,"phone":12,"phoneExt":12,"email":12},"Gary Hunter, MD",{"type":35,"investigatorFullName":388,"investigatorTitle":389,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Dr. Bijoy Menon","MD",[391],{"name":392,"class":6},"The George Institute for Global Health, Australia","100540714","phase-3-act-global-thrombolysis-act-when-001-domain-within-the-act-global-adaptive-platform-trial-nct06352632-100540714",false,"NCT06320431","ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632","A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants With Acute Ischemic Stroke (ACT-GLOBAL THROMBOLYSIS (ACT WHEN-001) Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL) NCT06352632","ACT-WHEN","Inclusion Criteria:\n\n1. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for emergency EVT are eligible.\n2. Consent process completed as per national laws and regulation and the applicable ethics committee requirements.\n\nExclusion Criteria:\n\n1. Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who are actively bleeding, had recent intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis.\n2. Minor stroke patients with non-disabling symptoms.","ALL","18 Years",{"count":404,"type":405},4000,"ESTIMATED","INTERVENTIONAL",[408],"PHASE3","This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.\n\nThis domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight), vs. low-dose intravenous tenecteplase (0.18 mg\u002Fkg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight), vs. low-dose intravenous tenecteplase (0.18 mg\u002Fkg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 48 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.\n\nThis domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:\n\n1. In patients with recent (48 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg\u002Fkg body weight) or low-dose tenecteplase (0.18 mg\u002Fkg) or not at all.\n2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.\n3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg\u002Fkg body weight) or low-dose tenecteplase (0.18 mg\u002Fkg).\n4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging.",[411,412,413],"Acute Ischemic Stroke AIS","Stroke Acute","Stroke, Acute, Stroke Ischemic",[415,416,417,26,418,419,420],"Stroke","Thrombolysis","Platform","Endovascular thrombectomy","EVT","Domain","2025-09-11",{"date":423,"type":424},"2025-09-17","ACTUAL",{"date":426,"type":424},"2024-09-26",{"date":428,"type":405},"2030-12-31",{"name":5,"class":6},24]