New treatment for 'Wake up Stroke'

Main Category: Stroke
Article Date: 10 Feb 2004 - 0:00 PDT

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Patients with 'wake up' stroke are unfortunate in that there is no current treatment (approved treatment). Thrombolytic theraby with abciximab could be effective, according to results of Phase 2a and Phase 2b trials.

At the American Stroke Association's 29th International Stroke Conference, two doctors - Antoni Davalos, MD, PhD, Section of Neurology, Hospital Universitari (Italy) and Doctor Josep Trueta, Girona (Spain) presented their findings. The conference took place in San Diego, USA.

'At least 20% of (stroke) patients wake up with symptoms of stroke and the actual time of onset is unknown,' Dr. Davalos said. 'As a result, they are denied effective therapy.'

The only treatment currently available is tissue plasminogen activator. This has to be administered within three hours of onset.

The researchers gathered data from two studies:

1. Phase 2a double-blind, placebo controlled dose escalation study that evaluated 4 doses of abciximab. 74 patients who presented within 24 hours of acute ischemic stroke were used in this study.

2. Phase 2b, double-blind study of 400 patients (presenting within 6 hours of stroke onset). In this study, patients were randomized to a 0.25mg/kg bolus of abciximab up to a maximum of 30 mg, followed by a 12-hour infusion of 0.125 mcg/kg/minute of abciximab, up to a maximum of 10 mcg/minute, or placebo.

43 patients in both trials had wake up stroked. This means that they went to bed the previous night normally (no symptoms at all) and woke up in the morning with a neurological deficit.

The trials were funded by Centocor, Inc (they make abciximab)

In the Phase 2a trial, National Institutes of Health Stroke Scores (NIHSS) in the abciximab arm decreased from an average of 15.1 at baseline to 10.5 at 3 months, while increasing in the placebo arm from a mean of 15.5 to 18.1. By 3 months, 11% in the abciximab group had died compared with 29% of patients in the placebo arm.

In the Phase 2b trial, NIHSS scores decreased from a mean of 11.7 at baseline to 6.6 at 3 months in the abciximab-treated patients, while increasing from 11.4 to 13.6 in the placebo-treated patients. By 3 months, 25% of the placebo-treated patients had died, while none who were treated with abciximab had died, Dr. Davalos reported.

None of the patients who had a 'wake up' stroke had an intracranial hemorrhage, he added.

'Abciximab seems to be safe in patients with wake up stroke and shows promise for treating them,' he concluded.

Based on the promising results, the researchers are embarking on the first trial that will randomize patients within 3 hours of waking up with symptoms of stroke to a thrombolytic agent or placebo, he said.

[Study title: Evaluation of the Safety and Efficacy of Abciximab in Subjects with 'Wake Up' Acute Ischemic Stroke: Insights from Two Randomized Double-Blind, Placebo-Controlled Trials. Abstract P185]

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