Still a ways to go, mRS score should be zero(No symptoms) for all treated. Only 2.2 percentage points better than placebo.
An example of its use here:
YOUR HEALTH: Putting your brain in hibernation
It has been a year and a half, has your stroke hospital done anything with this?
Your hospitals' reasons for doing nothing? There is absolutely no excuse for doing nothing.
Laziness? Incompetence? Or just don't care? No leadership? No strategy? Not my job?
Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial
Abstract
Background:
Nerinetide, an eicosapeptide that interferes with post-synaptic density
protein 95, is a neuroprotectant that is effective in preclinical stroke
models of ischaemia-reperfusion. In this trial, we assessed the
efficacy and safety of nerinetide in human ischaemia-reperfusion that
occurs with rapid endovascular thrombectomy in patients who had an acute
ischaemic stroke.
Methods:
For this multicentre, double-blind, randomised, placebo-controlled study
done in 48 acute care hospitals in eight countries, we enrolled
patients with acute ischaemic stroke due to large vessel occlusion
within a 12 h treatment window. Eligible patients were aged 18 years or
older with a disabling ischaemic stroke at the time of randomisation,
had been functioning independently in the community before the stroke,
had an Alberta Stroke Program Early CT Score (ASPECTS) greater than 4,
and vascular imaging showing moderate-to-good collateral filling, as
determined by multiphase CT angiography. Patients were randomly assigned
(1:1) to receive intravenous nerinetide in a single dose of 2·6 mg/kg,
up to a maximum dose of 270 mg, on the basis of estimated or actual
weight (if known) or saline placebo by use of a real-time, dynamic,
internet-based, stratified randomised minimisation procedure. Patients
were stratified by intravenous alteplase treatment and declared
endovascular device choice. All trial personnel and patients were masked
to sequence and treatment allocation. All patients underwent
endovascular thrombectomy and received alteplase in usual care when
indicated. The primary outcome was a favourable functional outcome 90
days after randomisation, defined as a modified Rankin Scale (mRS) score
of 0-2. Secondary outcomes were measures of neurological disability,
functional independence in activities of daily living, excellent
functional outcome (mRS 0-1), and mortality. The analysis was done in
the intention-to-treat population and adjusted for age, sex, baseline
National Institutes of Health Stroke Scale score, ASPECTS, occlusion
location, site, alteplase use, and declared first device. The safety
population included all patients who received any amount of study drug.
This trial is registered with ClinicalTrials.gov, NCT02930018.
Findings:
Between March 1, 2017, and Aug 12, 2019, 1105 patients were randomly
assigned to receive nerinetide (n=549) or placebo (n=556). 337 (61·4%)
of 549 patients with nerinetide and 329 (59·2%) of 556 with placebo
achieved an mRS score of 0-2 at 90 days (adjusted risk ratio 1·04, 95%
CI 0·96-1·14; p=0·35). Secondary outcomes were similar between groups.
We observed evidence of treatment effect modification resulting in
inhibition of treatment effect in patients receiving alteplase. Serious
adverse events occurred equally between groups.
Interpretation:
Nerinetide did not improve the proportion of patients achieving good
clinical outcomes after endovascular thrombectomy compared with patients
receiving placebo.
Funding:
Canadian Institutes for Health Research, Alberta Innovates, and NoNO.
No comments:
Post a Comment