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Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343174
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : June 22, 2006
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Brain Infarction Cerebral Ischemia Acute Stroke Drug: Ancrod Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343174

Sponsors and Collaborators
Heidelberg University
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Principal Investigator: M G Hennerici, MD Univ Heidelberg Klinikum Mannheim
Study Director: Jean M Orgogozo, MD Univ Bordeaux France
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00343174    
Other Study ID Numbers: MPR-CC-0101
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: June 22, 2006
Last Verified: January 2002
Keywords provided by Heidelberg University:
vascular diseases
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action