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

This study has been completed.

First Received on 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:	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:

MedlinePlus related topics: Vascular Diseases

Drug Information available for: Ancrod

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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 ClinicalTrials.gov Identifier (NCT Number):

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.

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 University of Heidelberg:

stroke
vascular diseases

Additional relevant MeSH terms:

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
Ancrod
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 February 09, 2012