PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.

Phase 1

• Conditions: Stroke (ischaemic stroke or intracerebral hemorrhage); MedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003179-32-HU
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-07
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3800

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3800

Exclusion Criteria

1. Active infection requiring antibiotic treatment, as judged by the treating physician;
2. Pre-stroke score on the mRS =4;
3. Death appearing imminent at the time of assessment.

In addition, patients will be excluded from participation in the trial treatment arms for any of the following reasons:
For the ceftriaxone arm:
1. Known hypersensitivity to beta-lactam antibiotics;
2. Clinical indication for antibiotic treatment; use of an antibiotic before screening is not an exclusion criterion.
For the paracetamol arm:
1. Known hypersensitivity to paracetamol or any of the excipients;
2. Known severe hepatic insufficiency;
3. Chronic alcoholism;
4. Clinical indication for the use of paracetamol; incidental use of paracetamol before screening is not an exclusion criterion.
For the metoclopramide arm:
1. Hypersensitivity to the metoclopramide or to any of the excipients;
2. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk;
3. Confirmed or suspected pheochromocytoma;
4. History of neuroleptic or metoclopramide-induced tardive dyskinesia;
5. Epilepsy;
6. Parkinson's disease;
7. Use of levodopa or dopaminergic agonists;
8. Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency;
9. Clinical indication for the use of metoclopramide; incidental use of metoclopramide before screening is not an exclusion criterion.

Study & Design

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