Viewing Study NCT06078995



Ignite Creation Date: 2024-05-06 @ 7:37 PM
Last Modification Date: 2024-10-26 @ 3:10 PM
Study NCT ID: NCT06078995
Status: RECRUITING
Last Update Posted: 2023-10-12
First Post: 2023-10-03

Brief Title: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
Sponsor: Huashan Hospital
Organization: Huashan Hospital

Study Overview

Official Title: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world Multicenter Retrospective Controlled Study
Status: RECRUITING
Status Verified Date: 2023-10
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: 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 45 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

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?: False
Is an FDA AA801 Violation?: None