Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268762
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2005-12-20
Brief Title:
Argatroban Stroke Treatment - A Pilot Safety Study
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With Tissue Plasmingen Activator TPA In Patients With Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Is the combination of low doses of argatroban in combination with rt-PA safe and does it increase recanalization in patients with acute ischemic stroke
Detailed Description:
All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines and who have an occluded middle cerebral artery documented on TCD receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 175 X baseline Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will determine the incidence of hemorrhage recanalization and reocclusion and serial neurological exam will determine the clinical outcome For patients without temporal windows a baseline CT-Angiogram CTA demonstrating arterial occlusion can also be enrolled In those patients a follow-up CTA 24-36 hours will be performed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50NS44227 project 2 | OTHER_GRANT | P50NS44227 | None |