Who is going to do that? I want a name.
http://www.thelancet.com/journals/laneur/article/PIIS1474-4422%2812%2970225-9/abstract
Background
Neuroprotection
with NA-1 (Tat-NR2B9c), an inhibitor of postsynaptic density-95
protein, has been shown in a primate model of stroke. We assessed
whether NA-1 could reduce ischaemic brain damage in human beings.
Methods
For
this double-blind, randomised, controlled study, we enrolled patients
aged 18 years or older who had a ruptured or unruptured intracranial
aneurysm amenable to endovascular repair from 14 hospitals in Canada and
the USA. We used a computer-generated randomisation sequence to
allocate patients to receive an intravenous infusion of either NA-1 or
saline control at the end of their endovascular procedure (1:1;
stratified by site, age, and aneurysm status). Both patients and
investigators were masked to treatment allocation. The primary outcome
was safety and primary clinical outcomes were the number and volume of
new ischaemic strokes defined by MRI at 12—95 h after infusion. We used a
modified intention-to-treat (mITT) analysis. This trial is registered
with ClinicalTrials.gov, number NCT00728182.
Findings
Between
Sept 16, 2008, and March 30, 2011, we randomly allocated 197 patients
to treatment—12 individuals did not receive treatment because they were
found to be ineligible after randomisation, so the mITT population
consisted of 185 individuals, 92 in the NA-1 group and 93 in the placebo
group. Two minor adverse events were adjudged to be associated with
NA-1; no serious adverse events were attributable to NA-1. We recorded
no difference between groups in the volume of lesions by either
diffusion-weighted MRI (adjusted p value=0·120) or fluid-attenuated
inversion recovery MRI (adjusted p value=0·236). Patients in the NA-1
group sustained fewer ischaemic infarcts than did patients in the
placebo group, as gauged by diffusion-weighted MRI (adjusted incidence
rate ratio 0·53, 95% CI 0·38—0·74) and fluid-attenuated inversion
recovery MRI (0·59, 0·42—0·83).
Interpretation
Our
findings suggest that neuroprotection in human ischaemic stroke is
possible and that it should be investigated in larger trials.
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