NL-OMON50714
Completed
Phase 3
PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment - PRECIOUS
niversitair Medisch Centrum Utrecht0 sites740 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- stroke
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 740
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. A clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage,
- •confirmed with CT or MRI scan. A normal CT scan is considered compatible with
- •ischaemic stroke;
- •2\. A score on the National Institutes of Health Stroke Scale (NIHSS) \* 6,
- •indicating moderately severe to severe stroke;
- •3\. Age 66 years or older;
- •4\. The possibility to start treatment within 24 hours of symptom onset;
- •5\. Written informed consent.
Exclusion Criteria
- •1\. Active infection requiring antibiotic treatment, as judged by the treating
- •2\. Pre\-stroke score on the mRS (modified Rankin Scale) \*4
- •3\. Death appearing imminent at the time of assessment.
Outcomes
Primary Outcomes
Not specified
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