Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132509
Status:
TERMINATED
Last Update Posted:
2011-07-22
First Post:
2005-08-19
Brief Title:
FRALYSE Trial Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Comparison of the Classical Rt-PA Procedure 09mgkg Over 60 Minutes With a Longer Procedure With Lower Dose 08mgkg Over 90 Minutes in Acute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
End of promotion by the sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke We the investigators at Hospices Civils de Lyon have designed a randomized protocol to test this hypothesis Moreover the therapeutic window is 7 hours
Rt-PA alteplase is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a classical dose and 90 minutes in the arm with a low dose-longer infusion
This is a study of the outcome at 90 days
Rt-PA alteplase is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a classical dose and 90 minutes in the arm with a low dose-longer infusion
This is a study of the outcome at 90 days
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