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

NCT00343174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-06-22

No results posted yet for this study

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.

Conditions

  • Brain Infarction
  • Cerebral Ischemia
  • Acute Stroke

Interventions

DRUG

Ancrod

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • M G Hennerici, MD · Univ Heidelberg Klinikum Mannheim

  • Jean M Orgogozo, MD · Univ Bordeaux France

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343174 on ClinicalTrials.gov