ESTAT
European Stroke Treatment with Ancrod Trial
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Status:
European trial terminated in March of 2000 after futility analysis at a pre-planned interim analysis. At that time 1222 patients had been enrolled. A 90-day mortality analysis of patient data from this interim data set showed that mortality was higher in ancrod than placebo patients.
Purpose:
To compare ancrod vs. placebo in the treatment of ischemic stroke patients.
Interventions:
Ancrod
Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.
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Location(s):
Europe, Australia, Israel.
Year Started:
1996
Year Finished:
2000
Year Presented:
2001
Design:
International, multi-center, double-blind, randomized, placebo-controlled trial of 1222 patients at 101 centers.
Inclusion Criteria
Ischemic stroke presenting within 6 hours of onset, sudden and persistent stroke-related neurological deficits, at least 18 years of age, baseline Scandinavian Stroke Scale (SSS) score excluding the gait item <40.
Exclusion Criteria
Intracranial hemorrhage and evolving large ischemic infarcts as detected by CT scan.
Patient Involvement:
Patients were randomized to receive ancrod administered by continuous infusion for 72 hours, followed by a single iv infusion each day for 2 days to reach and maintain a fibrinogen level of 4070 mg/dl.
Primary Outcome:
Barthel index 95100 or return to pre-stroke values after 3 months.
Secondary Outcome:
SSS, Rankin Scale and death after 3 months and outcome after one year.
Results:
Results indicate that Ancrod should not be recommended to stroke patients. At three-month follow-up, results between the Ancrod and placebo groups did not differ, with a functional success rate of 42% on both (p=0.94, 95% CI).
Source of Information:
JAMA 283:2395 (2000).
BASF press release.
Presented at XVII World Congress of Neurology [June 2001].
Lancet. 2006 Nov 25;368(9550):1871-8.
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Web Links and Publications:
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This information last updated on: 7/16/2008
Reviewed on: 07/16/2008.
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