Abciximab (ReoPro) in Acute Ischemic Stroke

Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening.

Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening.Condition: – Stroke Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Official Title: Abciximab(ReoPro) in Acute Ischemic Stroke: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria (Abbreviated)Diagnosis of acute ischemic stroke with onset within 6 hours prior to planned start of study agent administration Or for subjects who wake from sleep with symptom of acute ischemic stroke and planned start of study agent administration within 3 hours of the time when the subject woke up. Age >/= 18 years Written informed consent Exclusion Criteria (Abbreviated)ICH National Institutes of Health Stroke Scale (NIHSS) 22 Pre-stroke Barthel Index (BI) < 95 or modified Rankin Scale (mRS) >1 Persistent hypertension Thrombolytics within 7 days Expected Total Enrollment: 1800 Royal North Shore Hospital Dept Neurology/Stroke Service, Sydney, Australia; Not yet recruiting Susan Day 61 29 7511 895 Sday@doh.health.nsw.gov.au Geoffrey Herkes, Principal InvestigatorWestmead Hospital, Nr. Sydney, New South Wales, NSW, Australia; Not yet recruiting Nazih Beydoun 61 29 8455 062 Nazih_Beydoun@wsahs.nsw.gov.au Richard Lindley, Principal InvestigatorPrince of Wales Hospital, Sydney, New South Wales, 2031, Australia; Not yet recruiting Deborah Giles 61 29 3822 449 gilesd@sesahs.nsw.gov.au Alessandro Zagami, Principal InvestigatorRoyal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Not yet recruiting Noelene Davis 61 88 2222 985 ndavies2@mail.rah.sa.gov.au Thomas Kimber, Principal InvestigatorVictoriaAlfred Hospital, Stroke Research Unit, Dept. of Neurosciences, Melbourne, Victoria, 3004,