Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Change in infarct volume from baseline to day 5
研究概览
简要总结
Minocycline is the second generation of tetracycline. Because of its lipophilicity, it has high penetrance of blood-brain barrier. Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular pathways, such as antioxidant, anti-inflammatory, anti apoptotic pathways, and protection of blood-brain barrier. Clinical studies have also shown that minocycline can significantly improve 3-month National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) of patients with ischemic stroke, indicating that minocycline is a potential neuroprotective drug. Minocycline is believed to protect the blood-brain barrier, thereby reducing the ischemia-reperfusion injury caused by mechanical thrombectomy. However, whether minocycline can become a synergistic treatment method of mechanical thrombectomy, there is no clinical research in this area at present. Therefore, investigators carry out the study on the effect of minocycline in patients with acute anterior circulation ischemic stroke after mechanical thrombectomy, and plan to enroll 180 patients. To explore the safety and effectiveness of minocycline in patients with acute ischemic stroke after thrombectomy.
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
In this study, the outcome of minocycline group and routine treatment group was compared. Placebo control was not used, so outcomes assessor blind was used.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion;
- •Age 18-85 years old;
- •The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging;
- •The time of onset 6-24 hours, DWI shows an infarct volume less than 1/3 of the MCA blood supply area; the time of onset ≤ 6 hours, the ASPECTS(Alberta Stroke Program Early CT Score) is ≥6;
- •Preoperative NIHSS score ranges from 6 to 30 points;
- •Sign the informed consent form;
排除标准
- •There are contraindications for mechanical thrombectomy;
- •No revascularization therapy was performed during the operation or the TICI score after revascularization therapy was less than 2b;
- •There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc;
- •There is evidence that the patient has bacterial endocarditis, aortic dissection, arteritis or venous cerebral infarction;
- •Renal insufficiency or hepatic insufficiency (serum creatinine >2.0 mg/dL or 180 µmol/L; liver function greater than 3 times the normal value);
- •Known history of congestive heart failure (requiring dietary or medication changes or hospitalization) within 6 months, or myocardial infarction within 6 months;
- •There is evidence of any other life-threatening or severe diseases that may hinder the completion of the 3-month follow-up and affect the evaluation of the results;
- •Pre-existing neurological deficits or history of dementia;
- •There are infectious diseases that require antibiotic treatment before the disease;
- •Allergic to tetracyclines or unable to take minocycline for other reasons;
- •Minocycline could not be given within 1 hour after recanalization;
- •Pregnant patients;
- •Participated in another clinical trial within 30 days before inclusion in the study.
- •Refuse to sign the informed consent form.
研究组 & 干预措施
Routine treatment group
Patients were given mechanical thrombectomy and other standard treatment for acute ischemic stroke, without minocycline treatment.
Minocycline treatment group
Patients were given minocycline 200mg/d orally from the day of admission for 5 days. At the same time, the patient received mechanical thrombectomy and other standard treatments for acute ischemic stroke.
干预措施: Minocycline (Drug)
结局指标
主要结局
Change in infarct volume from baseline to day 5
时间窗: Day 5 after onset
Baseline infarct volume is measured by diffusion-weighted imaging (DWI), day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR), Images are processed by imSTROKE software.
次要结局
- Infarct volume at day 5 after onset(Day 5 after onset)
- Excellent outcome at 3 months after onset(3 months after onset)
- Mortality at 3 months after onset(3 months after onset)
- Functional outcome at 3 months after onset(3 months after onset)
- Favourable outcome at 3 months after onset(3 months after onset)
- Improvement of neurological function compared with baseline(day 1, day 3, day 5, day 7, and 3 months after onset)
- Improvement of activity of daily living at 3 months after onset(3 months after onset)
- Incidence of intracranial hemorrhage at day 1 after onset(Day 1 after onset)
- Length of hospital stay and length of Intensive Care Unit (ICU) stay(3 months after onset)
研究者
Wen Jiang-3
Professor
Xijing Hospital