Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588337
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-10-03
Brief Title:
INtravenous TNK for Acute isChemicsTroke in China
Sponsor:
General Hospital of Shenyang Military Region
Organization:
General Hospital of Shenyang Military Region
Study Overview
Official Title:
INtravenous TNK for Acute isChemicsTroke in China INTACT-China a Prospective Multi-center Registry Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Acute ischemic stroke is the most common type of stroke accounting for about 60-80 of all stroke with high incidence high mortality high disability rate has become the first cause of death in China At present only ultra-early thrombolytic therapy endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients Intravenous thrombolytic therapy within 45 hours after the onset of ischemic stroke symptoms has been shown to be effective which is recommended in the guidelines
In most countries alteplase R-tPA is the only drug approved for the treatment of acute ischemic stroke Recombinant human TNK tissue-type plasminogen activator rhTNK-tPA is a modified recombinant tissue-type plasminogen activator with no procoagulant effect and a longer half life In recent years there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke and TNK shows promising especially for large artery occlussion At present there are few reports on the application of rhTNK-tPA in Chinese stroke patients
The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective multicenter registration study
In most countries alteplase R-tPA is the only drug approved for the treatment of acute ischemic stroke Recombinant human TNK tissue-type plasminogen activator rhTNK-tPA is a modified recombinant tissue-type plasminogen activator with no procoagulant effect and a longer half life In recent years there are some studies on the comparison of therapeutic effects of TNK-tPA and RT-PA in patients with acute ischemic stroke and TNK shows promising especially for large artery occlussion At present there are few reports on the application of rhTNK-tPA in Chinese stroke patients
The aim of this study is to evaluate the efficacy and safety of rhTNK-tPA in Chinese patients with ischemic stroke in a prospective multicenter registration study
Detailed Description:
None
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