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

Acute Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343174
• Other study ID #: MPR-CC-0101
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2006
• Last updated: June 20, 2006

Study information

• Verified date: January 2002
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Acute Stroke
• Brain Infarction
• Cerebral Infarction
• Cerebral Ischemia
• Stroke

Intervention

Drug:
• Ancrod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University