PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

Phase 3

Completed

• Conditions: stroke; 10005908; 10004018; 10007963

• Registration Number: NL-OMON50714
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 740

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
physician;
2. Pre-stroke score on the mRS (modified Rankin Scale) *4
3. Death appearing imminent at the time of assessment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the score on the modified Rankin Scale (mRS) at<br /><br>90 days (± 14 days), as analysed with multiple regression.</p><br>