title: What's new in stroke? Phase III randomized clinical trials of 2012-2014.
abstract: BACKGROUND
  Randomized clinical trials provide the most reliable evidence to guide the management of stroke and threatened stroke and reflect the interests of the stroke research community. The spectrum of phase III randomized clinical trials in stroke has not been previously characterized.
  
  
  METHODS
  Phase III stroke randomized clinical trials published between 2012 and 2014 were identified by search of the Cochrane Central Register of Controlled Trials supplemented by recent publications known to the co-authors.
  
  
  RESULTS
  Thirty-four randomized clinical trials were included involving 85 770 participants: 20 acute stroke randomized clinical trials (32 590 patients), 11 stroke prevention randomized clinical trials (28 964 patients), and three randomized clinical trials in which stroke was a major component of a composite primary outcome involving nonstroke patients (24 216 patients). Twenty-two (65%) trials were international, and eight (24%) were industry sponsored. Drugs were tested in 21 (62%) randomized clinical trials, with devices (n = 9), surgery (n = 3), and diet (n = 1) in the remainder. Thirteen (38%) randomized clinical trials were stopped early: seven for futility, three for efficacy, two for harm, and one for budget/administrative reasons. Overall, the results of seven (21%) randomized clinical trials were positive, five (15%) equivocal, 18 (53%) negative, and four (12%) inconclusive. Considering positive and definitively negative randomized clinical trials testing currently used interventions, 11 (32%) randomized clinical trials have direct implications for clinical management.
  
  
  CONCLUSIONS
  The diversity of interventions, high-quality, and worldwide origins of recently published phase III randomized clinical trials reflects a vibrant international stroke research community. The current generation of stroke randomized clinical trials provides important guidance for stroke prevention and acute stroke care.
authors.affiliation: Stroke Program, Department of Neurology (Neurology), Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hart
authors.affiliation: Stroke Program, Department of Medicine (Neurology), Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
authors.forename: Kuan H
authors.initials: KH
authors.lastname: Ng
authors.affiliation: Stroke Program, Department of Medicine (Neurology), Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
authors.forename: Kanjana S
authors.initials: KS
authors.lastname: Perera
authors.affiliation: Stroke Program, Department of Medicine (Neurology), Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
authors.forename: Ashkan
authors.initials: A
authors.lastname: Shoamanesh
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D020521:Stroke / Q000628:therapy*
keywords: acute stroke treatment; anticoagulation; antiplatelet therapy; randomized clinical trials; secondary prevention; stroke