Evaluation of efficacy and safety of Cerebrolysin as add-on therapy in patients with acute stroke after failed recanalisation therapy
- Conditions
- Acute ischemic strokeCirculatory SystemStroke, not specified as haemorrhage or infarction
- Registration Number
- ISRCTN15233803
- Lead Sponsor
- niversity Hospital Centre Zagreb
- Brief Summary
2021 Results article in https://doi.org/10.1016/j.clineuro.2021.106767 (added 16/08/2021) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 (added 14/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
1. Aged 18 and over
2. Patients with acute ischemic stroke and initial NIHSS 8 or more
3. Treated in University Hospital Centre Zagreb with either thrombolytic therapy alone, or thrombolysis and thrombectomy, either proven by neuroimaging methods (MRI, MRA, DSA) or clinically (no change in NIHSS in the first 12 hours after recanalisation procedure) to fulfil the criteria of unsuccessful reperfusion
1. Haemorrhagic transition of a stroke on control CT scan after reperfusion therapy
2. Patients taking MAO inhibitors
3. Patients known to be allergic to the drug
4. Patients taking part in another trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome measured by modified Rankin Scale (mRS) after 12 months
- Secondary Outcome Measures
Name Time Method 1. Percentage of patients with haemorrhagic transformation assessed by control neuroimaging (brain CT and/or MRI) in 24 hours and 7 days interval since symptom onset<br>2. Mortality rate assessed by modified Rankin Scale (mRS) at any point during study follow-up (12 months)<br>3. Adverse events assessed by routine laboratory or clinical changes during treatment period with Cerebrolysin