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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Infarction Cerebral Ischemia Acute Stroke

Keywords

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stroke vascular diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Ancrod

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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M G Hennerici, MD

Role: PRINCIPAL_INVESTIGATOR

Univ Heidelberg Klinikum Mannheim

Jean M Orgogozo, MD

Role: STUDY_DIRECTOR

Univ Bordeaux France

References

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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. doi: 10.1016/S0140-6736(06)69776-6.

Reference Type DERIVED

PMID: 17126719 (View on PubMed)

Other Identifiers

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MPR-CC-0101

Identifier Type: -

Identifier Source: org_study_id