Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414499
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-ⅣTRACE Ⅳ
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
TNK-tPA Treatment for Acute Minor Ischemic StrokeA Multicenter ProspectiveRandomizedOpen Label Blinded-endpoint Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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 a multicenter prospective open-label blinded-endpoint randomized controlled design Participants with acute minor ischemic stroke baseline NIHSS5 accompanied with DWIFLAIR mismatch will be randomized 11 to 025mgkg intravenous tenecteplase or standard medical treatment
Detailed Description:
The study will be a multicenter prospective open-label blinded-endpoint randomized controlled trial 2 arms with 11 randomization Participants with acute minor ischemic stroke baseline NIHSS5 within 12 hours of symptoms onset symptom onset is defined by the last seen normal principle for wake-up stroke accompanied with measurable neurological deficit and DWIFLAIR mismatch will be enrolled The measurable neurological deficit is defined as impairment of language or motor function Participants will be randomized into 2 groups Intervention group rhTNK-tPA 025mgkg the maximum dose does not exceed 25mg Control group Standard medical care according to the guideline The primary endpoint is excellent functional outcome Modified Rankin Scale score mRS 0-1 at 90-day
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