Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343174
Status:
COMPLETED
Last Update Posted:
2006-06-22
First Post:
2006-06-20
Brief Title:
Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 benefitrisk ration if treatment starts within 3 hours ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusionexclusion criteria to avoid secondary complications possibly related to a longer time window
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None