CHIMES Protocol

CHIMES protocol was published in March 2009 in the International Journal of Stroke click here to be redirected to the journal website

The protocol is also available on www.ClinicalTrials.gov under the identifier NCT00554723.

Protocol Synopsis

Study Objective
To test the hypothesis that Neuroaid is superior to Placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity (6 ≤ NIHSS ≤ 14).

Study Population
Potential subjects are screened for eligibility at baseline.

Inclusion criteria:
A subject will be eligible for inclusion in the trial only if all the following criteria apply at baseline:

  • Subject is aged 18 years old and above
  • Subject is on anti-platelet therapy
  • Subject has a pre-stroke Modified Rankin Scale inferior or equal to 1
  • A female subject is eligible to participate in the trial if she is of non childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal)
  • Subjects or his/her legally acceptable representative is willing to provide written informed consent
  • Subject has a cerebral infarction with compatible imaging using Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
  • Time window is less than 72 hours after symptoms onset
  • Subject has cerebral infarction with an intermediate severity range 6≤NIHSS≤14

Exclusion criteria:
A subject will not be eligible for inclusion in the trial if any of the following criteria apply at baseline:

  • Subjects deemed unstable by investigator after thrombolysis treatment
  • Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
  • Subject has a rapidly improving neurological deficit
  • Subject has definite indication for full-dose or long-term anticoagulation therapy
  • Subject has other significant non-ischemic brain lesion which could affect function or disability
  • Subject has co-existing systemic diseases which may affect assessment or follow-up such as terminal cancer, renal failure (creatinine >200umol/L if known), cirrhosis, severe dementia or psychosis.
  • Subject has participated in another clinical trial within the last three months