Intraarterial and intravenous tirofiban
DrugIntraarterial and intravenous tirofiban after endovascular thrombectomy
Other names: Tirofiban
NCT Number: NCT06373042
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 IIb/IIIa 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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraarterial and intravenous tirofiban after endovascular thrombectomy
Other names: Tirofiban
Intraarterial and intravenous placebo after endovascular thrombectomy
Other names: Placebo
Time frame: 90 days post-randomization
modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: within 48 hours post-randomization
Measured with the arterial occlusive lesion (AOL) scale
Time frame: within 48 hours post-randomization
defined as NIHSS score at 48 hours after randomization is reduced by 8 or more compared to NIHSS score at randomization; or the NIHSS at 48 hours after randomization is 0 to 1
Time frame: 90 days post-randomization
Measured with the mRS
Time frame: 90 days post-randomization
defined as mRS score of 0-1
Time frame: 90 days post-randomization
defined as mRS score of 0-3
Time frame: 90 days post-randomization
European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score
Time frame: 1 year post-randomization
Measured with the mRS
Time frame: 1 year post-randomization
European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score
Time frame: within 48 hours post-randomization
using Heidelberg criteria to assess SICH
Time frame: within 48 hours post-randomization
using Heidelberg criteria to assess SICH
Time frame: 90 days post-randomization
Death from any cause
Time frame: 90 days post-randomization
such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc
Contact information is provided by the study sponsor or research team.
Thanh N. Nguyen, MD
CONTACT
Zhongming Qiu, MD
CONTACT
Zhongming Qiu
Other
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
Acronym: ADJUVANT-2
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