Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Infarction; Cerebral Ischemia; Acute Stroke
Intervention: Ancrod (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Heidelberg Official(s) and/or principal investigator(s):
M G Hennerici, MD, Principal Investigator, Affiliation: Univ Heidelberg Klinikum Mannheim
Jean M Orgogozo, MD, Study Director, Affiliation: Univ Bordeaux France
Summary
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can
only be administered if treatment starts within 3 hours after onset of symptoms. This results
in a still too small number of patients treated with rtPA ( < 15% in best clinical care
institutions ). Ancrod is a differently acting biological drug which has been used for a
long time but not for acute stroke treatment. STAT was the first RCT of medium size to show
a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed
closely related to STAT but with a longer 6 hours window and specifically extended
inclusion/exclusion criteria to avoid secondary complications possibly related to a longer
time window.
Clinical Details
Official title: Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years and above, both sexes
- Acute ischemic stroke with first symptoms within 6 hours of beginning
- Treatment after onset of symptoms
- SSS < 40 at baseline ( consciousness necessary )
Exclusion Criteria:
- Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation
- CT evidence of major signs of developing infarction
- Coma
- Prior strokes within 6 weeks
- Severe hypertension (> 220 systolic > 120 mm Hg diastolic)
- Baseline fibrinogen < 100 mg/dL
- Recent use of thrombolytic agents
- Recent or anticipated surgery
Locations and Contacts
Additional Information
Last updated: June 20, 2006
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