Tirofiban for Successful Endovascular Stroke Thrombectomy
NCT06373042 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 712
Last updated 2024-05-16
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 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.
Conditions
- Stroke, Acute Ischemic
Interventions
- DRUG
-
Intraarterial and intravenous tirofiban
Intraarterial and intravenous tirofiban after endovascular thrombectomy
- DRUG
-
Intraarterial and intravenous placebo
Intraarterial and intravenous placebo after endovascular thrombectomy
Sponsors & Collaborators
-
Mianyang Central Hospital
collaborator OTHER -
The Second Affiliated Hospital of Chongqing Medical University
collaborator OTHER -
The Second Hospital of Jiaozuo
collaborator UNKNOWN -
Chongzhou People's Hospital
collaborator UNKNOWN -
Xihua People's Hospital
collaborator UNKNOWN -
Xingguo People's Hospital
collaborator UNKNOWN -
Zhongming Qiu
lead OTHER
Principal Investigators
-
Zhongming Qiu, MD · The 903rd Hospital of PLA, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-31
- Primary Completion
- 2026-07-31
- Completion
- 2026-10-31
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