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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00343174
First received: June 20, 2006
Last updated: NA
Last verified: January 2002
History: No changes posted
  Purpose

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 Intervention Phase
Brain Infarction
Cerebral Ischemia
Acute Stroke
Drug: Ancrod
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Heidelberg University

Additional 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
Study First Received: June 20, 2006
Last Updated: June 20, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
stroke
vascular diseases

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

ClinicalTrials.gov processed this record on July 22, 2014