Open AccessPhase IIB/III Trial of Tenecteplase in Acute Ischemic Stroke
Author(s) -
E. Clarke Haley,
John L.P. Thompson,
James C. Grotta,
Patrick D. Lyden,
Thomas Hemmen,
Devin L. Brown,
Christopher Fanale,
Richard Libman,
Thomas Kwiatkowski,
R. Llinás,
Steven R. Levine,
Karen C. Johnston,
Richard Buchsbaum,
Gilberto Levy,
Bruce Lubotsky Levin
Publication year - 2010
Publication title -
stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.397
H-Index - 319
eISSN - 1524-4628
pISSN - 0039-2499
DOI - 10.1161/strokeaha.109.572040
Subject(s) - tenecteplase , medicine , modified rankin scale , clinical trial , stroke (engine) , fibrinolytic agent , interim analysis , randomized controlled trial , thrombolysis , tissue plasminogen activator , surgery , ischemic stroke , ischemia , myocardial infarction , mechanical engineering , engineering
Intravenous alteplase (rtPA) remains the only approved treatment for acute ischemic stroke, but its use remains limited. In a previous pilot dose-escalation study, intravenous tenecteplase showed promise as a potentially safer alternative. Therefore, a Phase IIB clinical trial was begun to (1) choose a best dose of tenecteplase to carry forward; and (2) to provide evidence for either promise or futility of further testing of tenecteplase versus rtPA. If promise was established, then the trial would continue as a Phase III efficacy trial comparing the selected tenecteplase dose to standard rtPA.
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