2022
A Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design
Albers G, Campbell B, Lansberg M, Broderick J, Butcher K, Froehler M, Schwamm L, Nouh A, Liebeskind D, Toy F, Yang M, Massaro L, Schoeffler M, Purdon B. A Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design. International Journal Of Stroke 2022, 18: 237-241. PMID: 35262424, DOI: 10.1177/17474930221088400.Peer-Reviewed Original ResearchConceptsAcute ischemic strokeInternal carotid arteryPlacebo-controlled trialRankin Scale scoreSymptom onsetDay 90Scale scoreMiddle cerebral artery occlusionEfficacy of tenecteplaseLate-window patientsSafety of tenecteplaseSymptomatic intracranial hemorrhageCerebral artery occlusionLarge vessel occlusionPhase IIIPrimary efficacy objectiveBetter clinical outcomesAdverse eventsArtery occlusionEndovascular thrombectomyIschemic strokeMCA occlusionClinical outcomesIntracranial hemorrhageSalvageable tissue
2016
Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke
von Kummer R, Mori E, Truelsen T, Jensen J, Grønning B, Fiebach J, Lovblad K, Pedraza S, Romero J, Chabriat H, Chang K, Dávalos A, Ford G, Grotta J, Kaste M, Schwamm L, Shuaib A, Albers G. Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke. Stroke 2016, 47: 2880-2887. PMID: 27803391, DOI: 10.1161/strokeaha.116.013715.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSymptomatic intracranial hemorrhageSerious adverse eventsAdverse eventsMRS scoreTreatment armsIntracranial hemorrhagePooled analysisDay 90Major artery occlusionIschemic stroke patientsRankin Scale scoreMajor cerebral arteriesHigh-grade stenosisSignificant clinical benefitExtended time windowIntravenous desmoteplaseArterial recanalizationArtery occlusionIntravenous treatmentIschemic strokePrimary outcomeCerebral arteryRecanalization rateStroke patients
2015
Safety and efficacy of desmoteplase given 3–9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial
Albers G, von Kummer R, Truelsen T, Jensen J, Ravn G, Grønning B, Chabriat H, Chang K, Davalos A, Ford G, Grotta J, Kaste M, Schwamm L, Shuaib A, Investigators D. Safety and efficacy of desmoteplase given 3–9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. The Lancet Neurology 2015, 14: 575-584. PMID: 25937443, DOI: 10.1016/s1474-4422(15)00047-2.Peer-Reviewed Original ResearchConceptsMajor cerebral arteriesHigh-grade stenosisRankin Scale scoreIschemic strokeSymptom onsetCerebral arteryDay 90Scale scorePlacebo-controlled phase 3 trialComputer-generated randomisation listMajor cerebral artery occlusionModified Rankin Scale scoreSymptomatic cerebral edemaSymptomatic intracranial hemorrhageBaseline National InstitutesHealth Stroke ScaleSerious adverse eventsCerebral artery occlusionPhase 3 trialModified Rankin ScaleRandomisation listStroke ScaleStudy drugAdverse eventsArtery occlusion
2008
Intravenous desmoteplase in patients with acute ischaemic stroke selected by MRI perfusion–diffusion weighted imaging or perfusion CT (DIAS-2): a prospective, randomised, double-blind, placebo-controlled study
Hacke W, Furlan A, Al-Rawi Y, Davalos A, Fiebach J, Gruber F, Kaste M, Lipka L, Pedraza S, Ringleb P, Rowley H, Schneider D, Schwamm L, Leal J, Söhngen M, Teal P, Wilhelm-Ogunbiyi K, Wintermark M, Warach S. Intravenous desmoteplase in patients with acute ischaemic stroke selected by MRI perfusion–diffusion weighted imaging or perfusion CT (DIAS-2): a prospective, randomised, double-blind, placebo-controlled study. The Lancet Neurology 2008, 8: 141-150. PMID: 19097942, PMCID: PMC2730486, DOI: 10.1016/s1474-4422(08)70267-9.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overBrain IschemiaCerebral HemorrhageDouble-Blind MethodFemaleFibrinolytic AgentsHumansInjections, IntravenousMagnetic Resonance ImagingMaleMiddle AgedPerfusionPlasminogen ActivatorsProspective StudiesSample SizeStrokeTomography, X-Ray ComputedTreatment FailureYoung AdultConceptsSymptomatic intracranial hemorrhageClinical response rateAcute ischemic strokeDiffusion-weighted imagingResponse rateNIHSS scoreIschemic strokeIntracranial hemorrhageLesion volumeDay 90Mortality ratePerfusion imagingScale scoreHealth Stroke Scale scoreMedian baseline NIHSS scoreModified Rankin Scale scoreMagnetic resonance perfusion imagingComposite of improvementBaseline NIHSS scorePlacebo-controlled studyStroke Scale scoreDose-ranging studyRankin Scale scoreSymptoms of strokeOnset of stroke