Design and baseline results of the monosialoganglioside early stroke trial. The EST Study Group.
OBJECTIVE
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, 15 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.
Rocca
W A
WA
Epidemiology and Clinical Research, Verona, Italy.
Dorsey
F C
FC
Grigoletto
F
F
Gent
M
M
Roberts
R S
RS
Walker
M D
MD
Easton
J D
JD
Bruno
R
R
Carolei
A
A
Sancesario
G
G
D000328:Adult; D002533:Cerebral Angiography; D002561:Cerebrovascular Disorders / Q000175:diagnosis / Q000188:drug therapy*; D015331:Cohort Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005677:G(M1) Ganglioside / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014463:Ultrasonography
D005677:G(M1) Ganglioside