Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessors are masked (blinded) to the treatment allocation, ensuring unbiased assessment of the primary and secondary outcomes. All other parties, including the investigators and care providers, are unmasked (open-label).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intra-arterial Tirofiban Treatment
Participants in this arm will receive immediate intra-arterial tirofiban (0.5 mg) infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. The infusion will be administered over 10 minutes (1 mL/min) at the time of complete recanalization.
干预措施: Tirofiban (Drug)
No Intra-arterial Tirofiban Treatment
Participants in this arm will receive no intra-arterial tirofiban infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. Standard care will be followed.
结局指标
主要结局
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days
时间窗: 90±7 Days
The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion
次要结局
- Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days(90±7 days)
- Proportion of Participants with mRS 0-3 at 90±7 Days(90±7 Days)
- Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours(48 hours)
- Any Intracranial Hemorrhage (ICH) within 48 Hours(48 hours)
- 90-Day All-Cause Mortality(90±7 days)
- Quality of Life (EQ-5D-5L) at 90±7 Days(90±7 days)
- Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours(48 hours)
- Health-Related Quality of Life at 90±7 Days(90±7 days)