Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587347
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Tirofiban on Early Neurological Deterioration After Intravenous Thrombolysis in Patients with Acute Ischemic Stroke an Open-label Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREND-2
Brief Summary:
A prospective multicenter randomized controlled open-label blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke
Detailed Description:
Intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA administered within 45 hours of symptom onset remains the standard treatment strategy for acute ischemic stroke However approximately 6-40 of patients experienced early neurological deterioration following intravenous thrombolysis among which more than 70 resulted from ischemic events with 20-34 due to early re-occlusion of the recanalized artery Augmented platelet activation triggered by the activated coagulation cascade and endothelial injury during rt-PA administration is recognized as one of the primary reasons for ischemic events after intravenous thrombolysis Early antiplatelet therapy following rt-PA effectively reduces neurological deterioration and improves functional outcomes However the current guidelines recommend that antiplatelet therapy should be initiated 24 hours after intravenous thrombolysis due to the potential risk of intracerebral hemorrhage
Tirofiban a glycoprotein GP IIbIIIa receptor inhibitor renowned for its rapid action high selectivity and short half-life has been found to exert a remarkable antiplatelet effect by effectively blocking the terminal pathway that triggers platelet aggregation One recent randomized trial found that among patients with acute non-cardioembolic ischemic stroke who presented within 24 hours of symptom onset intravenous tirofiban resulted in a lower likelihood of early neurological deterioration than oral aspirin without increasing the risk of intracranial hemorrhage or systematic bleeding Another randomized trial found that treatment with intravenous tirofiban administration was safe and significantly improved 3-month functional outcomes in patients who experienced early neurological deterioration or no improvement within 24 hours of intravenous thrombolysis compared with aspirin Furthermore our previous study found that early administration of tirofiban in patients with early neurological deterioration within the first 24 hours of intravenous thrombolysis did not increase the risk of symptomatic intracerebral hemorrhage any intracerebral hemorrhage or mortality In contrast it was associated with neurological improvement at 3 months However whether early administration of tirofiban can safely and effectively prevent neurological deterioration in patients with acute ischemic stroke treated with intravenous thrombolysis within 24 hours remains unclear while the subset of patients who may benefit from early antiplatelet therapy
Tirofiban a glycoprotein GP IIbIIIa receptor inhibitor renowned for its rapid action high selectivity and short half-life has been found to exert a remarkable antiplatelet effect by effectively blocking the terminal pathway that triggers platelet aggregation One recent randomized trial found that among patients with acute non-cardioembolic ischemic stroke who presented within 24 hours of symptom onset intravenous tirofiban resulted in a lower likelihood of early neurological deterioration than oral aspirin without increasing the risk of intracranial hemorrhage or systematic bleeding Another randomized trial found that treatment with intravenous tirofiban administration was safe and significantly improved 3-month functional outcomes in patients who experienced early neurological deterioration or no improvement within 24 hours of intravenous thrombolysis compared with aspirin Furthermore our previous study found that early administration of tirofiban in patients with early neurological deterioration within the first 24 hours of intravenous thrombolysis did not increase the risk of symptomatic intracerebral hemorrhage any intracerebral hemorrhage or mortality In contrast it was associated with neurological improvement at 3 months However whether early administration of tirofiban can safely and effectively prevent neurological deterioration in patients with acute ischemic stroke treated with intravenous thrombolysis within 24 hours remains unclear while the subset of patients who may benefit from early antiplatelet therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None