High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Cerebral vascular wall damage
研究概览
简要总结
This project investigates the impact of statins on cerebral vascular wall damage after mechanical thrombectomy. The investigators will undertake a multi-center, prospective, parallel-controlled, open-label, superiority randomized controlled study based on past research on intense lipid-lowering intervention trials. Patients undergoing post-thrombectomy will be divided into two groups: the test group and the control group. After surgery, the test group will be given a high dose of atorvastatin (80mg/day), followed by a standard dose (20mg/day). The control group will continue to receive the standard dose of atorvastatin (20mg/day). The investigators will compare the high-resolution vascular wall MRI characteristics (vascular wall enhancement, lumen stenosis rate, and so on) within 3-5 days of the operation, as well as the composite incidence of ischemic stroke, transient ischemic attack, intracranial hemorrhage 1 month postoperatively, and the modified Rankin Score 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
- None
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke;
- •With anterior circulation acute stroke who meet and receive emergency endovascular treatment;
- •CTA or DSA confirms anterior circulation intracranial arterial lesions, including MT of intracranial arteries (middle cerebral artery (MCA), internal carotid artery (ICA), basilar artery and/or vertebral artery and P1 segment of posterior cerebral artery (PCA);
- •Recanalization of blood vessels after operation (mTICI ≥ 2b grade)
排除标准
- •Placing permanent stents or other implants in the target artery
- •Can not receive HR-VWI examination of 3T MRI due to claustrophobia or unstable condition
- •Contraindications to MRI and/or intravenous gadolinium
研究组 & 干预措施
high-dose arm
The test group will undergo high-dose atorvastatin treatment (80mg/day) for the first 3 days after the mechanical embolectomy, transitioning to a standard dose (20mg/day) of atorvastatin thereafter.
干预措施: Atorvastatin 80mg (Drug)
standard-dose arm
a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy
干预措施: Atorvastatin 20mg (Drug)
结局指标
主要结局
Cerebral vascular wall damage
时间窗: within 5-7 days after MT
Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI
次要结局
- Target vessel stenosis rate(Within 5-7 days after MT)
- Perioperative complications(Within 30 days after MT)
- Neurological function evaluation(Within 90 days after MT)
研究者
Gao-jun Teng
Dean
Zhongda Hospital