Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion

Официальное название

Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion

Обзор

The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events? Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe. Participants will: Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days

Вмешательства

• Препарат Tirofiban
  Immediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min).

Первичные конечные точки

• Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days [Срок оценки: 90±7 Days]

Вторичные конечные точки (7)

• Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days [Срок оценки: 90±7 days]
• Proportion of Participants with mRS 0-3 at 90±7 Days [Срок оценки: 90±7 Days]
• Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours [Срок оценки: 48 hours]
• Any Intracranial Hemorrhage (ICH) within 48 Hours [Срок оценки: 48 hours]
• 90-Day All-Cause Mortality [Срок оценки: 90±7 days]
• Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours [Срок оценки: 48 hours]
• Health-Related Quality of Life at 90±7 Days [Срок оценки: 90±7 days]

Критерии участия

Критерии включения

Age ≥18 years; Last known well to arterial puncture within 0 to 24 hours; Preoperative imaging confirms anterior circulation large-vessel occlusion, including intracranial internal carotid artery occlusion or middle cerebral artery M1 or dominant M2 occlusion; Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 to 25; Baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on CT or DWI; Pre-stroke modified Rankin Scale (mRS) score ≤1; eTICI 2c to 3 complete recanalization achieved after mechanical thrombectomy, or spontaneous recanalization to eTICI 2c to 3 confirmed intraoperatively without further thrombectomy; Embolic occlusion with no residual fixed stenosis in the target vessel after thrombectomy; Written informed consent provided by the participant or legally authorized representative.

Критерии исключения

Pregnancy or breastfeeding; Active bleeding within the previous month or known severe bleeding tendency; Major underlying disease with life expectancy <6 months, or inability in the investigator's judgment to complete follow-up; Participation in another interventional clinical trial; Use of oral anticoagulants within 48 hours before symptom onset with INR >1.7, or recent use of direct oral anticoagulants not meeting institutional cessation or testing requirements; Platelet count <50 × 10\^9/L; Blood glucose <2.8 mmol/L or >22.2 mmol/L that cannot be corrected promptly Severe renal insufficiency, defined as eGFR <30 mL/min/1.73 m² or serum creatinine >2.5 mg/dL; Uncontrolled blood pressure, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite treatment; Imaging evidence of intracranial hemorrhage, or presence of an intracranial aneurysm, arteriovenous malformation, brain tumor, or other lesion associated with high bleeding risk; Bilateral acute cerebral infarction or multiple intracranial arterial occlusions Intraoperative vessel rupture, dissection, contrast extravasation, or other severe complications requiring a change in the standard anticoagulation strategy; Need for balloon angioplasty, permanent stent placement, or planned initiation of antiplatelet or anticoagulation therapy within 24 hours after the procedure; More than 3 thrombectomy passes or puncture-to-recanalization time >90 minutes; Use of an intraoperative intravenous heparin bolus, excluding heparinized saline flush; Suspected embolic stroke due to infection or infectious endocarditis; Severe allergy to contrast agents or tirofiban.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong Provincial Hospital, Affiliated to Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT07537933 · IA-Tirofiban-2026-1012 · SWYX:NO. 2026-1012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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