A Study assessing the use of Simvastatin in subarachnoid haemorrhage

Phase 1

• Conditions: subarachnoid haemorrhage; MedDRA version: 14.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2006-000277-30-GB
• 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: 2006-04-13
• Study Completion: 2014-01-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

Exclusion Criteria

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

Study & Design

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