{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T01:20:51Z","timestamp":1793496051028,"version":"4.5.0"},"reference-count":33,"publisher":"American Medical Association (AMA)","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Neurol"],"published-print":{"date-parts":[[2026,8,1]]},"abstract":"\n Importance<\/jats:title>\n Tenecteplase has advantages over standard-dose alteplase for acute ischemic stroke. A low-dose alteplase regimen (0.6 mg\/kg) remains the standard in Japan and is commonly used in several Asian countries.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether standard-dose tenecteplase at 0.25 mg\/kg achieves a higher rate of recanalization on the initial angiogram than low-dose alteplase at 0.6 mg\/kg in patients scheduled for mechanical thrombectomy. It is inevitable to generate evidence required to support potential regulatory approval of tenecteplase in Japan.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This investigator-initiated, multicenter, randomized, controlled, open-label, superiority trial was conducted from August 19, 2022, through March 13, 2025, with 3-month follow-up and was the first ever to compare tenecteplase (0.25 mg\/kg) with alteplase (0.6 mg\/kg) for acute ischemic stroke. Participants included patients with large-vessel-occlusion stroke eligible for intravenous thrombolysis within 4.5 hours of symptom onset followed by mechanical thrombectomy. A total of 221 patients were randomized and 218 who received trial drugs were included in the full analysis set (107 tenecteplase; 111 alteplase). These data were analyzed from July 2025 to December 2025.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients were randomly assigned in a 1:1 ratio to receive either intravenous tenecteplase or alteplase.<\/jats:p>\n <\/jats:sec>\n \n Main outcomes and measures<\/jats:title>\n The primary outcome was substantial reperfusion (modified Treatment in Cerebral Ischemia grade 2b to 3 or no retrievable thrombus) on the initial angiogram. Secondary outcomes included the 90-day modified Rankin Scale. Safety outcomes were symptomatic intracranial hemorrhage within 24 to 36 hours and mortality at 90 days.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 218 patients (mean [SD] age, 77.1 [12.0] years; 92 female and 126 male) who received trial drugs were included in the full analysis set (107 tenecteplase; 111 alteplase). Substantial reperfusion occurred in 10.3% of the standard-dose tenecteplase group vs 3.6% of the low-dose alteplase group (absolute difference, 6.5 percentage points; 90% CI, 0.89-12.1), meeting the prespecified success criterion. The estimated common odds ratio for a shift toward better 90-day functional outcome with tenecteplase was 1.47 (95% CI, 0.92-2.35). Rates of symptomatic intracranial hemorrhage (2.8% vs 1.8%) and mortality (6.5% vs 9.9%) were similar between tenecteplase and alteplase groups.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and relevance<\/jats:title>\n In this study, standard-dose tenecteplase (0.25 mg\/kg) prior to thrombectomy resulted in a higher rate of early substantial reperfusion compared with low-dose alteplase (0.6 mg\/kg), with comparable functional and safety outcomes. Standard-dose tenecteplase is a promising thrombolytic option in regions where low-dose alteplase is currently the standard of care.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Japan Registry of Clinical Trials Identifier:\n 051210055<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaneurol.2026.1590","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T15:30:20Z","timestamp":1780327820000},"page":"769","source":"Crossref","is-referenced-by-count":3,"title":["Standard-Dose Tenecteplase vs Low-Dose Alteplase for Acute Ischemic Stroke From Large-Vessel Occlusion"],"prefix":"10.1001","volume":"83","author":[{"given":"Manabu","family":"Inoue","sequence":"first","affiliation":[{"name":"Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, 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National Cerebral and Cardiovascular Center, Suita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuyuki","family":"Sakai","sequence":"additional","affiliation":[{"name":"Seijinkai Shimizu Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masatoshi","family":"Koga","sequence":"additional","affiliation":[{"name":"Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Iwasaki","sequence":"additional","affiliation":[{"name":"Department of Medical Innovation, The University of Osaka Hospital, Suita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohide","family":"Yoshie","sequence":"additional","affiliation":[{"name":"Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taketo","family":"Hatano","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Kokura Memorial Hospital, Kitakyushu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Kuwashiro","sequence":"additional","affiliation":[{"name":"Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Yoshimura","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Hyogo Medical University, Nishinomiya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Neuroendovascular Therapy, St. Marianna University Toyoko Hospital, Kawasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiichiro","family":"Nagata","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokai University Hospital, Isehara, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinari","family":"Nagakane","sequence":"additional","affiliation":[{"name":"Department of Neurology, Kyoto Second Red Cross Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Neurology and Cerebrovascular Medicine, Saitama Medical University International Medical Center, Hidaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumio","family":"Miyashita","sequence":"additional","affiliation":[{"name":"Department of Neurology, Kagoshima City Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazutaka","family":"Sonoda","sequence":"additional","affiliation":[{"name":"Department of Neurology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Fukuda","sequence":"additional","affiliation":[{"name":"Department of Cerebrovascular Medicine, St. Mary\u2019s Hospital, Kurume, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanta","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiko","family":"Une","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, National Cerebral and Cardiovascular Center, Suita, 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