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Clinical Trials/ISRCTN87656744
ISRCTN87656744
Completed
Phase 3

Cerebrolysin as Early add-on to REperfusion therapy and risk of HEmorrhagic Transformation after Ischemic Stroke (CEREHETIS). A prospective randomized active-control multicenter pilot study

State Autonomous Institution of Health Interregional Clinical Diagnostic Center0 sites341 target enrollmentFebruary 16, 2021
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ConditionsIschemic strokeCirculatory System

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Ischemic stroke
Sponsor
State Autonomous Institution of Health Interregional Clinical Diagnostic Center
Enrollment
341
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36973684/ results (added 28/03/2023) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 Results abstract European Stroke Organisation Conference 2021 (added 29/03/2023) 2023 Results article in https://doi.org/10.17116/jnevro202312308260 (added 11/09/2023) 2024 Other publications in https://doi.org/10.3389/fphar.2023.1288718 Post hoc analysis (added 22/01/2024) 2023 Abstract results in https://doi.org/10.1159/000534859 (added 23/01/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38512096/ Post hoc analysis (added 02/04/2024)

Registry
who.int
Start Date
February 16, 2021
End Date
November 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
State Autonomous Institution of Health Interregional Clinical Diagnostic Center

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with confirmed diagnosis of acute ischemic stroke (AIS)
  • •2\. Male or female gender
  • •3\. Age \=18 years
  • •4\. Admission to one of the sites within 4\.5 h after the AIS onset
  • •5\. Indications for intravenous thrombolytic therapy

Exclusion Criteria

  • •1\. Contraindications for intravenous thrombolytic therapy
  • •2\. Contraindications for Cerebrolysin
  • •3\. Signs of hemorrhagic transformation or intracranial hemorrhage on the screening CT scan
  • •4\. Any other concurrent life\-threatening medical condition

Outcomes

Primary Outcomes

Not specified

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