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

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ClinicalTrials.gov Identifier: NCT00343174
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : June 22, 2006
Sponsor:
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

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




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

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 ClinicalTrials.gov identifier (NCT number): NCT00343174


Sponsors and Collaborators
Heidelberg University
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00343174     History of Changes
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:
stroke
vascular diseases

Additional relevant MeSH terms:
Ancrod
Stroke
Infarction
Ischemia
Brain Ischemia
Cerebral Infarction
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action