Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT): a Prospective, Single Arm, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of favorable outcome
研究概览
简要总结
Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. Although sufficient recanalization after thrombectomy is more than 80%, HERMES study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. Artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. The investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. This study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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.
- •Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy.
- •Sufficient recanalization （TICI 2b-3）within 7 hours of stroke onset.
- •The availability of informed consent.
排除标准
- •insufficient recanalization（TICI < 2a）after endovascular treatment;
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage.
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）.
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.
- •Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
- •Patients with contraindication or allergic to any ingredient of drugs in our study.
- •Unsuitable for this clinical studies assessed by researcher.
研究组 & 干预措施
intra-arterial cocktail therapy
Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy
干预措施: intra-arterial cocktail therapy (Drug)
结局指标
主要结局
Proportion of favorable outcome
时间窗: 90 days
favorable outcome is defined as mRS 0-2
次要结局
- proportion of early neurological improvement(48 hours)
- Proportion of excellent outcome(90 days)
研究者
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region