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Clinical Trials/EUCTR2015-003179-32-GR
EUCTR2015-003179-32-GR
Active, not recruiting
Phase 1

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

niversity Medical Center Utrecht0 sites3,800 target enrollmentApril 10, 2017
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DrugsParacetamolCeftriaxoneMetoclopramide

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Medical Center Utrecht
Enrollment
3800
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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 12 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

Exclusion Criteria

  • •1\. Active infection requiring antibiotic treatment, as judged by the treating physician;
  • •2\. Clinical indication for one or more of the drugs tested in this patient;
  • •3\. Pre\-stroke score on the mRS \=4;
  • •4\. 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;
  • •For the paracetamol arm:
  • •1\. Known hypersensitivity to paracetamol or any of the excipients;
  • •2\. Known severe hepatic insufficiency;

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.Stroke (ischaemic stroke or intracerebral hemorrhage)MedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2015-003179-32-HUniversity Medical Center Utrecht3,800
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PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.Stroke (ischaemic stroke or intracerebral hemorrhage)MedDRA version: 22.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
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EUCTR2015-003179-32-NLniversity Medical Center Utrecht3,800
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 assessmentstroke100059081000401810007963
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