Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT06078995
Status:
UNKNOWN
Last Update Posted:
2023-10-12
First Post:
2023-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
Sponsor:
Huashan Hospital
Organization:
Study Overview
Official Title:
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
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:
TTT-AIS CHINA
Brief Summary:
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.
Detailed Description:
Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.
This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.
This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: