EUCTR2006-000277-30-SE进行中(未招募)1 期
Simvastatin in Aneurysmal Subarachnoidal Haemorrhage (STASH): a multicentre randomized controlled clinical phase III study - STASH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 803
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18-65 years
- •2. The admitting neurosurgeon has a high index of suspicion of a spontaneous aneurysmal subarachnoid haemorrhage (good clinical history with convincing CT findings).
- •3. Any clinical grade accepted provided there is a reasonable prospect of survival.
- •4. Delay to randomisation and initiation of trial medication, from the time of the presenting bleed, does not exceed 96 hrs.
- •5. Independent prior to SAH.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Unsalvageable patients: fixed dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy.
- •2. Alreadey taking statin therapy.
- •3. Those taking Warfarin-type drugs.
- •4. Pregnancy.
- •5. Known renal or hepatic impariment.
- •6. Suspected or known additional disease process, which threatens life expectancy (e.g. malignancy).
- •7. Known or strong suspicion of drug abuse, alcoholism or those who are unlikely to be amenable to 6 months follow up.
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