Design and baseline results of the monosialoganglioside early stroke trial

Walter A Rocca, F. C. Dorsey, F. Grigoletto, M. Gent, R. S. Roberts, M. D. Walker, J. D. Easton, R. Bruno, A. Carolei, G. Sancesario, C. Fieschi

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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, 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.

Original languageEnglish (US)
Pages (from-to)519-526
Number of pages8
JournalStroke
Volume23
Issue number4
StatePublished - Apr 1992
Externally publishedYes

Fingerprint

Stroke
Placebos
Peripheral Vascular Diseases
Cerebrum
Feasibility Studies
Random Allocation
North America
sialogangliosides
Double-Blind Method
Atrial Fibrillation
Multicenter Studies
Survivors
Therapeutics
Hypertension
Safety
Survival

Keywords

  • Cerebrovascular disorders
  • Clinical trials
  • Gangliosides

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Rocca, W. A., Dorsey, F. C., Grigoletto, F., Gent, M., Roberts, R. S., Walker, M. D., ... Fieschi, C. (1992). Design and baseline results of the monosialoganglioside early stroke trial. Stroke, 23(4), 519-526.

Design and baseline results of the monosialoganglioside early stroke trial. / Rocca, Walter A; Dorsey, F. C.; Grigoletto, F.; Gent, M.; Roberts, R. S.; Walker, M. D.; Easton, J. D.; Bruno, R.; Carolei, A.; Sancesario, G.; Fieschi, C.

In: Stroke, Vol. 23, No. 4, 04.1992, p. 519-526.

Research output: Contribution to journalArticle

Rocca, WA, Dorsey, FC, Grigoletto, F, Gent, M, Roberts, RS, Walker, MD, Easton, JD, Bruno, R, Carolei, A, Sancesario, G & Fieschi, C 1992, 'Design and baseline results of the monosialoganglioside early stroke trial', Stroke, vol. 23, no. 4, pp. 519-526.
Rocca WA, Dorsey FC, Grigoletto F, Gent M, Roberts RS, Walker MD et al. Design and baseline results of the monosialoganglioside early stroke trial. Stroke. 1992 Apr;23(4):519-526.
Rocca, Walter A ; Dorsey, F. C. ; Grigoletto, F. ; Gent, M. ; Roberts, R. S. ; Walker, M. D. ; Easton, J. D. ; Bruno, R. ; Carolei, A. ; Sancesario, G. ; Fieschi, C. / Design and baseline results of the monosialoganglioside early stroke trial. In: Stroke. 1992 ; Vol. 23, No. 4. pp. 519-526.
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