[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tenecteplase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tenecteplase":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,69,87,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100620466","phase-3-intra-arterial-tenecteplase-for-acute-medium-vessel-occlusion-stroke-100620466",false,"NCT07357987","Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke","Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke: the ANGEL-MeVO-TNK Randomized Clinical Trial","ANGEL-MeVO-TNK","Inclusion Criteria:\n\nClinical Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Pre-stroke mRS 0-1;\n3. Within 24 h from symptom onset;\n4. Baseline National Institutes of Health Stroke Scale (NIHSS) score \\>5 or baseline NIHSS 3-5 with disabling deficit (e.g., loss of hand function, aphasia, hemianopia);\n5. Informed consent obtained from patients or their legal representatives.\n\nImaging Inclusion Criteria:\n\n1. Baseline CTA\u002FMRA\u002FDSA diagnosed isolated MeVO, referring to the M2\u002FM3 segment of the MCA, the A1\u002FA2\u002FA3 segment of the ACA, the P1\u002FP2\u002FP3 segment of the PCA;\n2. NCCT or MRI DWI imaging showing that the territory of the ischemic infarct volume is less than 50% of the estimated territory supplied by the occluded artery.\n\nExclusion Criteria:\n\n1. Acute intracranial hemorrhage;\n2. ASPECT ≤5;\n3. MeVO secondary to spontaneous fragmentation and distal migration of thrombus from an acute large vessel occlusion, or occurring after intravenous thrombolysis (IVT), intra-arterial thrombolysis, or endovascular thrombectomy;\n4. Contraindication to TNK;\n5. Known severe allergy to contrast agents (excluding mild rash-type allergic reactions);\n6. Use of heparin or novel oral anticoagulants within the previous 48 hours with an INR ≥ 1.7;\n7. A history of major bleeding within the past 6 months or the presence of conditions such as active gastrointestinal ulcer, aortic dissection, platelet count \\\u003C 100 × 10⁹\u002FL, etc.;\n8. Radiologically confirmed vascular malformations, arterial dissection, intracranial aneurysm (diameter≥3 mm), tumors (except small meningiomas), cerebral vasculitis, cerebral amyloid angiopathy, or other major non-ischemic intracranial diseases (e.g., multiple sclerosis);\n9. Acute renal failure, current dialysis, or estimated glomerular filtration rate (eGFR)\\\u003C30ml\u002Fmin\u002F1.72m2, and\u002For serum creatinine\\>220mmol\u002FL (2.5mg\u002Fdl);\n10. History of severe liver disease, or aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) and\u002For glutamyl transferase (GGT) ≥3×upper limit of normal value (ULN) and\u002For total bilirubin (TBIL) ≥2×ULN;\n11. Severe non-cardiovascular comorbidity with an expected life expectancy of less than 3 months (e.g., malignant tumors);\n12. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization;\n13. Current participation in another drug or device clinical trial;\n14. Any other condition deemed by the investigator to make the patient unsuitable for participation in the study or to pose a significant risk to the patient (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to psychiatric illness, cognitive impairment, or emotional disorders).","ALL","18 Years",{"count":20,"type":21},488,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The ANGEL-MeVO-TNK is a multicentered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. A total of 488 AIS patients (age ≥18 years) with acute MeVO-AIS (occlusion of the M2\u002FM3, the A1\u002FA2\u002FA3, the P1\u002FP2\u002FP3, and with baseline NIHSS score \\>5 or disabling stroke with NIHSS score 3-5 \\[such as neurological deficits in motor strength, language, vision, etc\\]), will be enrolled. Patients fulfilling all the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into the IA TNK group or the control group after offering informed content.\n\n* The IA TNK group：1) If the patient has not received IVT, IA TNK will be administered as a slow, continuous infusion for super-selective contact thrombolysis in a stepwise manner: an initial dose of 0.0625 mg\u002Fkg with a duration of 15 minutes. A repeat angiographic assessment will then be performed; if recanalization is not achieved, an additional dose of 0.0625 mg\u002Fkg will be administered over a further 15 minutes (maximum dose 12.5 mg) .\n\n  2\\) If the patient has received IVT, intra-arterial TNK will be administered as a slow infusion for super-selective contact thrombolysis at a dose of 0.0625 mg\u002Fkg (maximum dose 6.25 mg) with a duration of 15 minutes.\n* The control group will be given standard medical management.\n\nThe study consists of four visits including the day of randomization, 48±12 hours after randomization, and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program.\n\nThe primary outcome is the modified Rankin Scale (mRS) score of 0 to 1 at 90±7 days after onset. The primary safety outcome is the incidence of sICH within 48±12 hours after randomization (ECASS III).",[27,28,29,30],"Ischemic Stroke","Medium Vessel Occlusion","Tenecteplase","Endovascular Treatment","RECRUITING","2026-04-26",{"date":34,"type":35},"2026-04-30","ACTUAL",{"date":37,"type":35},"2026-01-22",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"Beijing Tiantan Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100629535","intravenous-tenecteplase-in-very-old-patients-with-acute-ischemic-stroke-100629535","NCT07475936","Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke","A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke","Inclusion Criteria:\n\n1. Age \\> 80 years;\n2. Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;\n3. Informed consent signed by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Any contraindication to intravenous thrombolysis (excluding age);\n2. Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;\n3. Current participation in other interventional studies;\n4. The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and\u002For follow-up).","80 Years",{"count":53,"type":21},392,"90 Days","OBSERVATIONAL","The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.",[58,29],"Acute Ischemic Stroke","NOT_YET_RECRUITING","2026-03-13",{"date":62,"type":35},"2026-03-17",{"date":64,"type":21},"2026-04",{"date":66,"type":21},"2027-12",{"name":68,"class":42},"First Affiliated Hospital of Guangxi Medical University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},"100629536","phase-3-unknown-time-of-onset-stroke-reperfusion-without-advanced-imaging-100629536","NCT07475949","Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging","Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial","UTOPIA","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Clinical diagnosis of acute ischemic stroke.\n3. Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time \\>4.5 hours.\n4. Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.\n5. National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).\n6. Pre-stroke modified Rankin Scale (mRS) score of 0-1.\n7. Written informed consent from patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.\n2. Rapid neurological improvement with NIHSS \\\u003C6 at randomization.\n3. Allergy to tenecteplase.\n4. Use of vitamin K antagonist with INR \\>1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.\n5. Hypodensity on non-contrast CT \\>1\u002F3 middle cerebral artery territory.\n6. Severe traumatic brain injury or other major trauma in the past 3 months.\n7. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).\n8. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.\n9. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.\n10. Active internal bleeding.\n11. Aortic dissection.\n12. Infective endocarditis.\n13. Platelet count \\\u003C100×10\\^9\u002FL.\n14. Women who are pregnant or breastfeeding.\n15. Blood glucose \\\u003C50 or \\>400 mg\u002FdL (\\\u003C2.78 or \\>22.2 mmol\u002FL).\n16. Systolic blood presure \\>185 mmHg or diastolic blood presure \\>110 mmHg refractory to treatment.\n17. Life expectancy \\\u003C3 months.\n18. Participating in other trials.\n19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to psychiatric disorders, cognitive or emotional impairment).",{"count":78,"type":21},352,[24],"The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.",[58,29],{"date":62,"type":35},{"date":64,"type":21},{"date":85,"type":21},"2028-12",{"name":68,"class":42},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":43},"100605880","phase-3-tenecteplase-vs-medical-management-in-45-24h-lvo-no-access-to-evt-100605880","NCT07168278","Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT","Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT","TNK LATE","Inclusion Criteria:\n\n* Age 18 years or greater\n* Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).\n* Prestroke mRS 0-2\n* NIHSS 6 to 25\n* Aspect ≥ 7\n* ICA terminus, M1, dominant M2 occlusion on CTA or MRA\n* Clinical-imaging mismatch assessed by investigator\n* Patients with no access to EVT at the time of randomization\n\nExclusion Criteria:\n\n* Current or past history of significant bleeding over the past 6 months;\n* History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;\n* Known bleeding tendency;\n* Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;\n* History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury；\n* Tumors that increase risk of bleeding;\n* Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;\n* Know arterial \u002F venous malformation or aneurysm;\n* Bacterial endocarditis, pericarditis, or acute pancreatitis;\n* Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR \\> 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range);\n* Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range;\n* Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury;\n* Over the past 2 weeks, receiving prolonged ( \\>2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture);\n* Stroke episode occurred with epileptic seizure;\n* History of stroke comorbid with diabetes;\n* History of stroke over the past 3 months；\n* Acute bleeding tendency, including platelet count below 100×10⁹\u002FL or other conditions;\n* SBP \\>185 mmHg or DBP \\>110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits;\n* Blood glucose \\\u003C2.8 mmol\u002FL or \\>22.2 mmol\u002FL (\\\u003C50 mg\u002FdL or \\>400 mg\u002FdL)；\n* Patient life expectancy of less than 1 year;\n* Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery;\n* Pregnant women or nursing mothers；\n* Patients with a low likelihood of 3-month follow-up；\n* Over the past 3 months participated in other interventional clinical trials.",{"count":96,"type":21},794,[24],"The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\\* Receive 0.25mg\u002Fkg (max 25mg) tenectplase at admission (after randomization) .\\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.",[58,100,29,101],"Large Vessel Occlusion","Thrombolysis","2025-09-05",{"date":104,"type":35},"2025-09-11",{"date":106,"type":21},"2025-11-01",{"date":108,"type":21},"2028-05-31",{"name":110,"class":42},"The First Affiliated Hospital of University of Science and Technology of China",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":43},"100563819","a-real-world-study-of-tenecteplase-versus-alteplase-for-thrombolysis-in-patients-within-45-h-of-onset-of-ischemic-stroke-100563819","NCT06621121","A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke","Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）","TRANSIT","Inclusion Criteria:\n\n\\- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.\n\n3\\. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.\n\nExclusion Criteria:\n\n* 1\\. Any absolute contraindication to thrombolysis in the \\"Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\\" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.",{"count":120,"type":21},6000,"Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.",[123,29,124],"Stroke Acute","Alteplase",[126,127,128],"ischemic stroke","tenecteplase","alteplase","2024-10-26",{"date":131,"type":35},"2024-10-29",{"date":129,"type":21},{"date":134,"type":21},"2026-10-01",{"name":136,"class":42},"Tianjin Huanhu Hospital"]