title: How baseline severity affects efficacy and safety outcomes in acute ischemic stroke intervention trials.
abstract: Baseline severity of stroke may be an important predictor of efficacy and safety outcomes in acute stroke intervention trials. This summary explores definitions of baseline variables and outcomes used to measure stroke severity, efficacy, and safety. In addition, the discussion here reviews select acute ischemic stroke intravenous thrombolytic studies, such as the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study and European Cooperative Acute Stroke Studies, select neuroprotectant and endovascular clot retrieval device studies, and large cooperative databases, such as the Virtual International Stroke Trials Archive and Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry, to explore relationships between baseline stroke severity and other possible factors associated with efficacy and safety outcomes. The NIH Stroke Scale and modified Rankin scale will be featured as major stroke outcome measures, based on frequency of use and reliability, familiarity, adaptability, and comparability.
authors.affiliation: Hauenstein Neuroscience Center, St. Mary's Hospital, Grand Rapids, Michigan, USA. pgorelic@trinity-health.org
authors.forename: Philip B
authors.initials: PB
authors.lastname: Gorelick
mesh_terms: D000208:Acute Disease; D000925:Anticoagulants / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D001925:Brain Damage, Chronic / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control / Q000601:surgery; D002543:Cerebral Hemorrhage / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002544:Cerebral Infarction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002548:Cerebral Revascularization / Q000295:instrumentation / Q000379:methods*; D002986:Clinical Trials as Topic; D057510:Endovascular Procedures; D023381:Endpoint Determination; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D016166:Free Radical Scavengers / Q000627:therapeutic use; D006801:Humans; D015337:Multicenter Studies as Topic; D018696:Neuroprotective Agents / Q000627:therapeutic use; D010960:Plasminogen Activators / Q000627:therapeutic use; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D017131:Thrombectomy / Q000295:instrumentation / Q000379:methods*; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D005343:Fibrinolytic Agents; D016166:Free Radical Scavengers; D018696:Neuroprotective Agents; C069588:salivary plasminogen activator alpha 1, Desmodus rotundus; D010960:Plasminogen Activators; D010959:Tissue Plasminogen Activator; D001241:Aspirin