Simvastatin in Aneurysmal Subarachnoidal Haemorrhage (STASH): a multicentre randomized controlled clinical phase III study - STASH

Phase 1

• Conditions: Subarachnoid haemorrhage

• Registration Number: EUCTR2006-000277-30-SE
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-23
• Study Completion: 2014-01-10
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 803

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can acute statin therapy improve outcome following rupture of an intracranial aneurysm resulting in a subarachnoid haemorrhage (SAH)?;Secondary Objective: 1. Does acute statin therapy improve the quality of survival following a SAH?<br>2. Will acute statin therapy reduce the need for intensve care, intensity of support therapy and total acute hospital stay compared to a placebo?<br>3. Will the use of statin therapy increase the percentage of patients being discharged directly home?;Primary end point(s): Clinical outcome at 6 months