Cerebral Ischemia

February 13, 2012

Merck released results from a clinical trial of vorapaxar, under development for the prevention of thrombosis and the reduction of cardiovascular events. TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) was a secondary prevention study in 26,449 subjects with a heart attack, an ischemic stroke, or documented peripheral vascular disease. The subjects received vorapaxar plus standard of care or standard of care alone. The addition of vorapaxar to standard of care significantly reduced the risk of the primary endpoint of the composite of cardiovascular death, heart attack, stroke or urgent coronary revascularization compared to standard of care. There was a significant increase in bleeding, including intracranial hemorrhage, among subjects taking vorapaxar in addition to standard of care.

Remedy Pharmaceuticals reported results from a phase IIa trial of RP-1127 for the treatment of ischemic stroke. This multi-center, prospective, open label trial, GAMES-Pilot, enrolled 10 subjects with severe anterior circulation ischemic stroke who were likely to experience clinically significant brain swelling. The subjects received RP-1127 as an intravenous bolus followed by infusion for 72 hours. Results were compared to historical data. Treatment with RP-1127 showed an incidence of major swelling in 12.5% of the subjects versus 88% in the historical group. No significant hemorrhages were observed versus 30% in the historical group and the proportion of subjects without severe disability or death at 30 days was 87.5% versus one-third in the historical group. Follow up Magnetic Resonance Imaging showed absence of midline shift and ventricle compression, striking preservation of sulci, and preservation of white matter.

March 3, 2008

Stem Cell Therapeutics issued positive results from a phase IIa trial of NTx-265 for the treatment of acute ischemic stroke. This open-label study, dubbed BETAS (Beta-hCG + Erythropoietin in Acute Stroke), enrolled thirteen subjects at two sites in California. The subjects received treatment with NTx-265 within twenty four to forty eight hours of stroke onset. Of the thirteen subjects, eight completed the ninety day assessment term and each of them showed a clinically relevant improvement in their National Institutes of Health Stroke Scale (NIHSS) score of four points or greater. The average baseline NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved at day ninety to 2.5 plus/minus 1.8, an improvement in NIHSS score of 5.8 plus/minus 2.5 points. Five of these eight subjects had a day ninety Barthel Index score of 95-100 (out of 100); consistent with excellent outcome. NTx-265 also led to positive specific assessments of neurological recovery, including the Arm Motor Fugl-Meyer Scale, an arm motor recovery assessment; Trailmaking A test, a measure of cognitive function; and measures of neglect and aphasia. In addition, NTx-265 decreased the size of the infarct in six out of eight subjects overall, given a mean decrement in all eight of about 10%. A phase IIb study is expected to commence later in 2008.

March 10, 2003

Texas Biotechnology and GlaxoSmithKline reported positive results from a phase II trial investigating Argatroban, a synthetic direct thrombin inhibitor for the treatment of ischemic stroke. Results showed the drug produced Intracranial Hemorrhaging (ICH) at a rate comparable to placebo. The primary endpoint of safety, defined as symptomatic intracranial hemorrhage within 30 days, confirmed by computerized tomography, was successfully met with no statistically significant differences between the treatment group vs. placebo. The secondary endpoints, defined as asymptomatic ICH, major systemic hemorrhage, minor systemic bleeding, and efficacy for each group and stroke showed no significant differences from placebo. The double- blind, randomized study, called ARGIS-I (Argatroban in Acute Ischemic Stroke), enrolled 176 ischemic stroke subjects. Subjects were given Argatroban or placebo to achieve two different levels of anticoagulation within 12 hours from symptom onset.

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