Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745259
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2023-02-16
Brief Title:
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients 3T Stroke-Ⅲ
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients a Multi-center Block Randomized Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial 3T Stroke-Ⅲ
Status:
RECRUITING
Status Verified Date:
2023-02
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:
The trial is prospective randomized open-label blinded endpoint PROBE design Patients with acute ischemic stroke who are eligible for standard intravenous thrombolysis within 45 hours of stroke onset will be randomized 11 to 025mgkg or 09 mgkg alteplase before all participants undergo endovascular thrombectomy
Detailed Description:
The study will be a multi-center prospective randomized open- label blinded endpoint PROBE controlled phase 3 trial 2 arm with 11 randomization in ischemic stroke patients Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours The sample size is 1630
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None