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

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.

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Key information

Conditions

Brain Infarction Acute Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Ischemia Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ancrod

Drug

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study 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

Important dates

First posted: Jun 22, 2006
Registry last updated: Jun 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed