Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498323
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2022-06-13
Brief Title:
Intravenous TNK vs TPA for AIS Treatment on MSUa Prospective Multicenter RCT
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units a Prospective Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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 one of the devastating diseases that increase hospitalization disabilities and deaths worldwide Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 45 hours and without contraindications
Tenecteplase a genetically engineered tissue-type plasminogen activator has been questioned to treat acute ischemic stroke instead of intravenous alteplase Tenecteplase has more advantages over alteplase including higher fibrin specificity longer half-life and easier to administer as a single intravenous bolus The efficacy and safety of intravenous tenecteplase has been studied recently In 2017 A phase 3 randomized open-label blinded trial NOR-TEST 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients A study in 2020 in the setting of acute large artery occlusion Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10 Regarding safety concerns tenecteplase showed no significant higher incidence of intracerebral hemorrhage Administration tenecteplase might be better in the setting of the case on mobile stroke units Assuming earlier reperfusion by thrombolytic drug may have improved patients neurologic outcomes We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 45 hours after symptom onset
Tenecteplase a genetically engineered tissue-type plasminogen activator has been questioned to treat acute ischemic stroke instead of intravenous alteplase Tenecteplase has more advantages over alteplase including higher fibrin specificity longer half-life and easier to administer as a single intravenous bolus The efficacy and safety of intravenous tenecteplase has been studied recently In 2017 A phase 3 randomized open-label blinded trial NOR-TEST 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients A study in 2020 in the setting of acute large artery occlusion Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10 Regarding safety concerns tenecteplase showed no significant higher incidence of intracerebral hemorrhage Administration tenecteplase might be better in the setting of the case on mobile stroke units Assuming earlier reperfusion by thrombolytic drug may have improved patients neurologic outcomes We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 45 hours after symptom onset
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