Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 22
- 主要终点
- Poor functional outcome
研究概览
简要总结
The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.
详细描述
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.
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)
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
- •Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
- •Age 18-80 years;
- •Hematoma located in the supratentorial region;
- •Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
- •Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
- •Glasgow Coma Scale (GCS) score ≥9;
- •Baseline hematoma volume of 5-35 mL;
- •Signed informed consent obtained.
排除标准
- •ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
- •Patients who have undergone or are scheduled for immediate surgical intervention;
- •Pregnancy or lactation;
- •Use of oral anticoagulants within 1 month prior to symptom onset;
- •Pre-stroke mRS >1;
- •Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;
- •Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.
研究组 & 干预措施
Atorvastatin Treatment plus Best Medical Treatment
Patients in this group will receive atorvastatin treatment plus best medical treatment.
干预措施: Atorvastatin Treatment (Drug)
Atorvastatin Treatment plus Best Medical Treatment
Patients in this group will receive atorvastatin treatment plus best medical treatment.
干预措施: Best Medical Treatment (Other)
Best Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
干预措施: Best Medical Treatment (Other)
结局指标
主要结局
Poor functional outcome
时间窗: 90 ± 7 days
The proportion of poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
次要结局
- Functional independence(90 ± 7 days)
- Ordinal distribution of mRS(90 ± 7 days)
- Changes in hematoma volume from baseline to 24 ± 12 hours(24 ± 12 hours)
- Changes in hematoma volume from baseline to 7 ± 1 days(7 ± 1 days)
- Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days(between 24 ± 12 hours and 7 ± 1 days)
- Changes in perihematomal edema (PHE) volume from baseline to 7 ± 1 days(7 ± 1 days)
- Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days(7 ± 1 days)
研究者
Qi Li
Professor
The Second Hospital of Anhui Medical University