Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NL-OMON50714
NL-OMON50714CompletedPhase 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 enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
740
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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.

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Similar Trials

Active, not recruiting
Phase 1
PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.
EUCTR2015-003179-32-GRniversity Medical Center Utrecht3,800
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 disorders
EUCTR2015-003179-32-HUniversity Medical Center Utrecht3,800
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: 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 disorders
EUCTR2015-003179-32-ITIVERSITY MEDICAL CENTER UTRECHT3,800
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: 19.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disorders
EUCTR2015-003179-32-NLniversity Medical Center Utrecht3,800
Completed
Not Applicable
Interventions to reduce complications of tracheal intubation.
CTRI/2021/11/038089Dr Supradip Ghosh56