Cerebrolysin as an Early Add-on to Reperfusion Therapy: Risk of Hemorrhagic Transformation after Ischemic Stroke (CEREHETIS), a prospective, randomized, multicenter pilot study.

Khasanova DR, Kalinin MN

BMC neurology27 Mar 2023Cited by 25 (Europe PMC)

PMID36973684PMCIDPMC10041692DOI10.1186/s12883-023-03159-wPepBankPUB-36973684

Summary

BackgroundCerebrolysin could mitigate reperfusion injury and hemorrhagic transformation (HT) in animal models of acute ischemic stroke.MethodsThis was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study. Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone. The primary outcomes were the rate of any and symptomatic HT assessed from day 0 to 14. The secondary endpoints were drug safety and functional outcome measured with the National Institutes of Health Stroke Scale (NIHSS) on day 1 and 14, and the modified Rankin scale (mRS) on day 90. Advanced brain imaging analysis was applied on day 1 and 14 as a marker for in vivo pharmacology of Cerebrolysin.ResultsCerebrolysin treatment resulted in a substantial decrease of the symptomatic HT rate with an odds ratio (OR) of 0.248 (95% CI: 0.072-0.851; p = 0.019). No serious adverse events attributed to Cerebrolysin occurred. On day 14, the Cerebrolysin arm showed a significant decrease in the NIHSS score (p = 0.045). However, no difference in the mRS score was observed on day 90. A substantial improvement in the advanced brain imaging parameters of the infarcted area was evident in the Cerebrolysin group on day 14.ConclusionsEarly add-on of Cerebrolysin to reperfusion therapy was safe and significantly decreased the rate of symptomatic HT as well as early neurological deficit. No effect on day 90 functional outcome was detected. Improvements in the imaging metrics support the neuroprotective and blood-brain barrier stabilizing activity of Cerebrolysin.Trial registrationName of Registry: ISRCTN.Trial registration numberISRCTN87656744 . Trial Registration Date: 16/02/2021.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In ischemic stroke patients receiving alteplase, Cerebrolysin reduced symptomatic hemorrhagic transformation compared with alteplase alone.
In plain wordsIn stroke patients, Cerebrolysin with alteplase reduced symptomatic brain bleeding compared with alteplase alone.
Peptide
Cerebrolysin
Outcome
DecreaseSymptomatic hemorrhagic transformation
Study
n = 341
Comparator
Alteplase alone
Analysis
Primary
Outcome group
Adverse events · Nervous system and cognition
Studied dose
30 mL/day · 14 daysAs given in this study (human).
Measurements
Odds ratio
0.248 ratio
Symptomatic HT
95% CI
0.072 to 0.851 ratio
Symptomatic HT
p value for symptomatic HT odds ratio
0.019
Cerebrolysin plus alteplase versus alteplase alone, symptomatic HT
Source sentences
Summary
Cerebrolysin treatment resulted in a substantial decrease of the symptomatic HT rate with an odds ratio (OR) of 0.248 (95% CI: 0.072-0.851; p = 0.019).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.
Summary · context
Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone.
Show in the study text Report a problemFND-3697368401
02HumanRandomized controlled trialEfficacy outcome
In ischemic stroke patients receiving alteplase, adding Cerebrolysin significantly decreased the NIHSS score on day 14 compared with alteplase alone.
In plain wordsIn stroke patients receiving alteplase, adding Cerebrolysin lowered stroke severity scores on day 14 more than alteplase alone.
Peptide
Cerebrolysin
Outcome
DecreaseNIHSS on day 14
Study
n = 341
Comparator
Alteplase alone
Analysis
Secondary
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 mL/day · 14 daysAs given in this study (human).
Measurements
p value for NIHSS decrease
0.045
NIHSS decrease in the Cerebrolysin arm on day 14
Source sentences
Summary
On day 14, the Cerebrolysin arm showed a significant decrease in the NIHSS score (p = 0.045).
3 context sentences(design, population, supporting numbers)
Summary · context
Early add-on of Cerebrolysin to reperfusion therapy was safe and significantly decreased the rate of symptomatic HT as well as early neurological deficit.
Summary · context
This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.
Summary · context
Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone.
Show in the study text Report a problemFND-3697368403
03HumanRandomized controlled trialEfficacy outcome
In ischemic stroke patients receiving alteplase, day 90 mRS scores did not differ between Cerebrolysin and alteplase-alone groups.
In plain wordsIn stroke patients, day 90 disability scores did not differ between Cerebrolysin with alteplase and alteplase alone.
Peptide
Cerebrolysin
Outcome
No significant changemRS on day 90
Study
n = 341
Comparator
Alteplase alone
Analysis
Secondary
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 mL/day · 14 daysAs given in this study (human).
Source sentences
Summary
However, no difference in the mRS score was observed on day 90.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.
Summary · context
Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone.
Show in the study text Report a problemFND-3697368404
04HumanRandomized controlled trialSafety outcome
In ischemic stroke patients receiving alteplase and Cerebrolysin, no serious adverse events attributed to Cerebrolysin occurred.
In plain wordsIn stroke patients receiving alteplase and Cerebrolysin, no serious adverse events attributed to Cerebrolysin occurred.
Peptide
Cerebrolysin
Outcome
No significant changeSerious adverse events attributed to Cerebrolysin
Study
n = 126
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
30 mL/day · 14 daysAs given in this study (human).
Source sentences
Summary
No serious adverse events attributed to Cerebrolysin occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.
Summary · context
Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone.
Show in the study text Report a problemFND-3697368402
05HumanRandomized controlled trialMechanism
In ischemic stroke patients receiving alteplase, the Cerebrolysin group showed improved imaging parameters of the infarcted area on day 14.
In plain wordsIn stroke patients receiving alteplase, the Cerebrolysin group showed improved imaging measurements of the damaged brain area on day 14.
Peptide
Cerebrolysin
Outcome
Direction not reportedAdvanced brain imaging parameters
Study
n = 126
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
30 mL/day · 14 daysAs given in this study (human).
Source sentences
Summary
A substantial improvement in the advanced brain imaging parameters of the infarcted area was evident in the Cerebrolysin group on day 14.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study.
Summary · context
Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone.
Show in the study text Report a problemFND-3697368405

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownEarly phase 1NCT06489925

Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion

University Hospital Sestre Milosrdnicen = 20est. Jul 2024 to est. May 2026

Basilar Artery Occlusion · Posterior Circulation Brain Infarction

Trial page ClinicalTrials.govUpdated 9 Jul 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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