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

This study has been completed.

First Received: June 20, 2006 No Changes Posted

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00343174

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 III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Ancrod

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343174

Sponsors and Collaborators

University of Heidelberg

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 University of Heidelberg

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	MPR-CC-0101
Study First Received:	June 20, 2006
Last Updated:	June 20, 2006
ClinicalTrials.gov Identifier:	NCT00343174 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

stroke
vascular diseases

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ancrod
Ischemia

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on February 08, 2010