Simvastatin in aneurysmal subarchnoid haemorrhage (STASH): a multicentre randomised controlled clinical phase III study - STASH

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 803 人开始时间: 2006年4月13日最近更新: 2019年6月30日

试验速览

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•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 96hrs.
•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 800
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Unsalvageable patients: fixed dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy
•2. Already taking statin therapy
•3. Those taking Warfarin- type drugs
•4. Pregnancy
•5. Known renal or hepatic impairment
•6. Suspected or known additional disease process, which threatens life expectency (e.g. malignancy)
•7. Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to 6 month follow up

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