Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 522
- 试验地点
- 1
- 主要终点
- Utility-Weighted Modified Rankin Scale
研究概览
简要总结
A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage
详细描述
To further explore the efficacy and safety of ultra-early statin administration in aSAH, we propose a Phase III randomized controlled trial-The Ultra-early Statin in patients with Aneurysmal subArachnoid hemorrhage (Ue-STAR) trial. This study aims to determine whether ultra-early (within 6 hours), short-term treatment (2 weeks) with a high intensive long-acting statin (atorvastatin 40 mg/day) improves clinical outcomes at 6 months in aSAH patients. Through this research, we hope to provide more robust evidence for the clinical management of aSAH, ultimately improving treatment outcomes for patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; Aged ≥18 years
- •Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
- •Treatment within 6 h after symptom onset
排除标准
- •Treatment with statin prior SAH
- •Non-aSAH (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation)
- •Treatment > 6 h after symptom onset
- •Allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis
- •Evidence of irreversible brain damage or expected death within 7 days
- •Known severe liver or kidney disease
- •Non-compliance with follow-up
- •Pregnant or breastfeeding
- •History of severe cranial or psychiatric illness
- •Concomitant serious systemic disease
- •Patients with malignant tumors
- •Currently participating in another clinical trial
- •Considered unsuitable for the clinical trial by clinical physicians or researchers
研究组 & 干预措施
Atorvastatin group
On the basis of routine treatment for aneurysmal subarachnoid hemorrhage, atorvastatin was administered at an ultra early stage at a dose of 40mg/d for 14 consecutive days
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Utility-Weighted Modified Rankin Scale
时间窗: 6 months after discharge
A utility-weighted Modified Rankin Scale (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. Utility values were 1.0 for Modified Rankin Scale (mRS) level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Higher scores mean a better outcome.
次要结局
- Modified Rankin Scale Score(6 months after discharge)
- The 5-level EQ-5D version(6 months after discharge)
- Glasgow Outcome Scale Extended(6 months after discharge)