title: Effects of MLC601 on early vascular events in patients after stroke: the CHIMES study.
abstract: OBJECTIVE
  Early vascular events are an important cause of morbidity and mortality in the first 3 months after a stroke. We aimed to investigate the effects of MLC601 on the occurrence of early vascular events within 3 months of stroke onset.
  
  
  METHODS
  Post hoc analysis was performed on data from subjects included in the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study, a randomized, placebo-controlled, double-blinded trial that compared MLC601 with placebo in 1099 subjects with ischemic stroke of intermediate severity in the preceding 72 hours. Early vascular events were defined as a composite of recurrent stroke, acute coronary syndrome, and vascular death occurring within 3 months of stroke onset.
  
  
  RESULTS
  The frequency of early vascular events during the 3-month follow-up was significantly less in the MLC601 group than in the placebo group (16 [2.9%] versus 31 events [5.6%]; risk difference=-2.7%; 95% confidence interval, -5.1% to -0.4%; P=0.025) without an increase in nonvascular deaths. Kaplan-Meier survival analysis showed a difference in the risk of vascular outcomes between the 2 groups as early as the first month after stroke (Log-rank P=0.024; hazard ratio, 0.51; 95% confidence interval, 0.28-0.93).
  
  
  CONCLUSIONS
  Treatment with MLC601 was associated with reduced early vascular events among subjects in the CHIMES study. The mechanisms for this effect require further study.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00554723.
authors.affiliation: From the Department of Pharmacology, National University of Singapore, Singapore (C.L.H.C.); Raffles Neuroscience Centre, Raffles Hospital, Singapore (N.V.); Singapore Clinical Research Institute, Singapore (C.F.L.); Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories (K.S.L.W.); Lariboisière University Hospital, Paris, France (M.-G.B.).
authors.forename: Christopher L H
authors.initials: CL
authors.lastname: Chen
authors.forename: Narayanaswamy
authors.initials: N
authors.lastname: Venketasubramanian
authors.forename: Chun Fan
authors.initials: CF
authors.lastname: Lee
authors.forename: K S Lawrence
authors.initials: KS
authors.lastname: Wong
authors.forename: Marie-Germaine
authors.initials: MG
authors.lastname: Bousser
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D000368:Aged; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D055502:Secondary Prevention; D020521:Stroke / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018696:Neuroprotective Agents
keywords: Neuroaid; clinical trial; secondary prevention; stroke; vascular diseases