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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 20, 2006 | ||||||||
| Last Updated Date | June 20, 2006 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Ancrod | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | Hennerici MG, Kay R, Bogousslavsky J, Lenzi GL, Verstraete M, Orgogozo JM; ESTAT investigators. Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial. Lancet. 2006 Nov 25;368(9550):1871-8. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00343174 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | MPR-CC-0101 | ||||||||
| Study Sponsor ICMJE | University of Heidelberg | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Heidelberg | ||||||||
| Verification Date | January 2002 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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