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

NCT00343174 | Completed Phase 3

• 1 other identifier: MPR-CC-0101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

stroke; vascular diseases

Interventions

Ancrod DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Related Publications (1)

• 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.

  PMID: 17126719 DERIVED

MeSH Terms

Conditions

Brain Infarction; Brain Ischemia; Stroke; Vascular Diseases

Interventions

Ancrod

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Venombin A; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Crotalid Venoms; Viper Venoms; Snake Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• M G Hennerici, MD

  Univ Heidelberg Klinikum Mannheim

  PRINCIPAL INVESTIGATOR

• Jean M Orgogozo, MD

  Univ Bordeaux France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 22, 2006
• Last Updated: June 22, 2006

Record last verified: 2002-01