Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373042
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-15
Brief Title:
Tirofiban for Successful Endovascular Stroke Thrombectomy
Sponsor:
Zhongming Qiu
Organization:
Xinqiao Hospital of Chongqing
Study Overview
Official Title:
Efficacy and Safety of Tirofiban Versus Placebo After Successful Reperfusion With Endovascular Thrombectomy in Acute Ischemic Stroke Patients With Anterior Circulation Large Vessel Occlusion a Multicenter Double-Blind Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ADJUVANT-2
Brief Summary:
Up to 50 of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy a phenomenon that is referred to as futile recanalization The mechanism of futile recanalization is complex and some studies have shown that it may be related to factors such as tissue no reflow reocclusion poor status of collateral circulation hemorrhagic transformation impaired cerebrovascular autonomic regulation and low perfusion volume Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion In animal models of cerebral ischemia downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy
Mechanical thrombectomy mainly addressed the occluded large arteries and does not consider the distal arteries However the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries Even with complete recanalization impaired microcirculatory reperfusion may lead to poor clinical outcomes Therefore we speculate that at the end of endovascular thrombectomy microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart Therefore intra-arterial administration of pharmaceutical such as tirofiban may be the only possible option to ensure complete reperfusion of ischemic tissue Tirofiban is a platelet glycoprotein IIbIIIa receptor antagonist which has been widely used in acute coronary syndrome and its role in acute ischemic stroke has attracted more and more attention from stroke experts Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization while reducing the reocclusion rate
Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear
Mechanical thrombectomy mainly addressed the occluded large arteries and does not consider the distal arteries However the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries Even with complete recanalization impaired microcirculatory reperfusion may lead to poor clinical outcomes Therefore we speculate that at the end of endovascular thrombectomy microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart Therefore intra-arterial administration of pharmaceutical such as tirofiban may be the only possible option to ensure complete reperfusion of ischemic tissue Tirofiban is a platelet glycoprotein IIbIIIa receptor antagonist which has been widely used in acute coronary syndrome and its role in acute ischemic stroke has attracted more and more attention from stroke experts Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization while reducing the reocclusion rate
Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear
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