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NCT00731627 · ClinicalTrials.gov registry record · Phase 3
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
A Phase 3 study of Subarachnoid Haemorrhage, sponsored by Cambridge University Hospitals NHS Foundation Trust.
- Completed
- Registry status
- Phase 3
- Development phase
- 803
- Enrollment target
- 2
- Study locations
NCT00731627 is a Phase 3 study of Subarachnoid Haemorrhage that has completed, run by Cambridge University Hospitals NHS Foundation Trust. The registered enrollment target is 803 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00731627, a Phase 3 study of Subarachnoid Haemorrhage, has completed, sponsored by Cambridge University Hospitals NHS Foundation Trust.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 803 participants
- Enrollment target
- 2
- Study locations
Study Summary
Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH. The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).
Conditions Studied
Interventions
- DRUG placebo
- DRUG simvastatin
Study Locations (2)
Florida
- Dept of Neurological Surgery, University of Florida - Gainesville
- Mayo Clinic - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 803 participants |
| Start Date | 2007-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731627
The ClinicalTrials.gov registry entry for NCT00731627 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 803 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cambridge University Hospitals NHS Foundation Trust, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Subarachnoid Haemorrhage appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00731627 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT00731627 about?
NCT00731627 is a clinical study titled "Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial". Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which ...
What is the current status of trial NCT00731627?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2007-01. Estimated completion is 2014-02.
What conditions does trial NCT00731627 study?
This clinical trial studies the following conditions: Subarachnoid Haemorrhage.
What interventions are being tested in trial NCT00731627?
The interventions under investigation include: placebo (DRUG), simvastatin (DRUG).
Who is sponsoring clinical trial NCT00731627?
This trial is sponsored by Cambridge University Hospitals NHS Foundation Trust, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00731627 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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