TY - JOUR
T1 - Design and baseline results of the monosialoganglioside early stroke trial
AU - Rocca, W. A.
AU - Dorsey, F. C.
AU - Grigoletto, F.
AU - Gent, M.
AU - Roberts, R. S.
AU - Walker, M. D.
AU - Easton, J. D.
AU - Bruno, R.
AU - Carolei, A.
AU - Sancesario, G.
AU - Fieschi, Cesare
PY - 1992/4
Y1 - 1992/4
N2 - Background and Purpose: The Early Stroke Trial is a randomized, placebo-controlled, double-masked, multicenter study to assess the safety and efficacy of monosialoganglioside in patients who have suffered an ischemic stroke of the cerebral hemispheres. Methods: Only patients who could be evaluated and treated within 5 hours after the onset of stroke were considered; within each center, subjects were stratified by age, sex, and clinical severity. Patients were randomly allocated to receive a specified sequence of intravenous and intramuscular doses of either monosialoganglioside or identical-appearing placebo for 21 days. Patients were followed up for 4 months after randomization. Neurological status was measured primarily by using the Canadian Neurological Scale. After assessing the effect of treatment on survival, the principal measure of efficacy will be the change in neurological status between baseline and the 4-month follow-up among survivors. Results: Sixteen clinical centers, IS in Europe and one in North America, entered a total of 792 eligible patients during a 36-month recruitment period (from May 1987 to April 1990). In our series there were more men than women, and the relative frequency of patients increased with advancing age. The most frequently associated cardiovascular conditions were hypertension, atrial fibrillation, and peripheral vascular disease. Approximately 46% of the patients were admitted to a hospital within 1 hour and 81%, within 2 hours after the onset of stroke. About 22% first received the study treatment within 3 hours and 57%, within 4 hours. Conclusions: This study demonstrates the feasibility of large-scale trials with the onset of treatment within 5 hours after an ischemic stroke.
AB - Background and Purpose: The Early Stroke Trial is a randomized, placebo-controlled, double-masked, multicenter study to assess the safety and efficacy of monosialoganglioside in patients who have suffered an ischemic stroke of the cerebral hemispheres. Methods: Only patients who could be evaluated and treated within 5 hours after the onset of stroke were considered; within each center, subjects were stratified by age, sex, and clinical severity. Patients were randomly allocated to receive a specified sequence of intravenous and intramuscular doses of either monosialoganglioside or identical-appearing placebo for 21 days. Patients were followed up for 4 months after randomization. Neurological status was measured primarily by using the Canadian Neurological Scale. After assessing the effect of treatment on survival, the principal measure of efficacy will be the change in neurological status between baseline and the 4-month follow-up among survivors. Results: Sixteen clinical centers, IS in Europe and one in North America, entered a total of 792 eligible patients during a 36-month recruitment period (from May 1987 to April 1990). In our series there were more men than women, and the relative frequency of patients increased with advancing age. The most frequently associated cardiovascular conditions were hypertension, atrial fibrillation, and peripheral vascular disease. Approximately 46% of the patients were admitted to a hospital within 1 hour and 81%, within 2 hours after the onset of stroke. About 22% first received the study treatment within 3 hours and 57%, within 4 hours. Conclusions: This study demonstrates the feasibility of large-scale trials with the onset of treatment within 5 hours after an ischemic stroke.
KW - Cerebrovascular disorders
KW - Clinical trials
KW - Gangliosides
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U2 - 10.1161/01.STR.23.4.519
DO - 10.1161/01.STR.23.4.519
M3 - Article
C2 - 1561683
AN - SCOPUS:0026568197
SN - 0039-2499
VL - 23
SP - 519
EP - 526
JO - Stroke
JF - Stroke
IS - 4
ER -