Add-on benefit of cerebrolysin to acute stroke patients given recombinant tissue plasminogen activator
| ISRCTN | ISRCTN61644835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61644835 |
| Secondary identifying numbers | BGHMC-REC-2023-22 |
- Submission date
- 19/06/2025
- Registration date
- 03/07/2025
- Last edited
- 03/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is the third leading cause of death and disability in the Philippines. This study aims to determine if cerebrolysin has an add-on benefit to patients receiving thrombolysis, which involves the use of drugs to break down and dissolve blood clots.
Who can participate?
Patients 18 years old and above diagnosed with moderate to severe stroke who would receive thrombolysis therapy, admitted at Baguio General Hospital and Medical Center
What does the study involve?
Participants are randomly allocated to be treated with either cerebrolysin or a placebo.
What are the possible benefits and risks of participating?
Benefits include improved motor and cognitive deficits of stroke patients and decreased brain bleeding. Risks include fever and allergic reactions.
Where is the study run from?
Baguio General Hospital and Medical Center and East Avenue Medical Center (Philippines)
When is the study starting and how long is it expected to run for?
May 2024 to August 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Peter Allan A. Quitasol, peterallanquitasol@gmail.com
Contact information
Public, Scientific, Principal Investigator
Baguio General Hospital and Medical Center
Baguio City
2600
Philippines
 ORCID ID |
0009-0007-6150-5503 |
|---|---|
| Phone | +63 (0)917 585 5131 |
| peterallanquitasol@gmail.com |
Study information
| Study design | Randomized open-label multi-center prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available |
| Scientific title | Multi-center trial on the efficacy of cerebrolysin in acute ischemic stroke after intravenous thrombolysis |
| Study acronym | CERECAP |
| Study objectives | Among thrombolyzed patients with moderate to severe acute ischemic stroke (NIHSS >10) does cerebrolysin improve neurologic outcomes? |
| Ethics approval(s) |
Approved 24/05/2024, BGHMC Research Ethics Committee (BGH compound Gov Pack Road, Baguio City, 2600, Philippines; +63 (0)74 661 7910; rec@bghmc.doh.gov.ph), ref: BGHMC REC 2023-22 |
| Health condition(s) or problem(s) studied | Acute ischemic stroke after intravenous thrombolysis |
| Intervention | Patients will be randomized using the research randomizer to either the treatment group or the control group. The research randomizer (randomizer.org) is a free online software used to generate random numbers or assign participants to different groups. Patients randomized to the treatment group will be given Cerebrolysin at a dose of 30 cc IV infusion for 15 minutes for 21 days by the stroke nurse in charge. The initial dose will be given within 1 hour after thrombolysis in a separate IV line. The drug should be immediately given once opened. The infusion set will be changed daily to prevent infection. The venous line must be rinsed before and after the application with plain normal saline solution (NSS). If, however, the patient can already be discharged, Cerebrolysin infusion will be continued at home and will be given by a nurse trained to give the drug. The control group will receive a placebo (plain NSS). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Cerebrolysin |
| Primary outcome measure | Degree of independence or disability measured using the Modified Rankin Scale (MRS) at discharge and 3 months |
| Secondary outcome measures | 1. Symptomatic ICH assessed using CT scan at baseline (admission), 24 hours and 5 days 2. Degree of cognitive dysfunction measured using the Montreal Cognitive Assessment (MoCA) test at 3 months 3. Degree of stroke severity measured using the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) at baseline (admission), 24 hours, discharge and 3 months |
| Overall study start date | 23/05/2024 |
| Completion date | 22/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. >18 years old 2. Having an acute ischemic stroke within 4.5 hours post-ictus, moderate to severe stroke with NIHSS 10-25 on admission 3. Meets criteria for intravenous thrombolysis |
| Key exclusion criteria | 1. Hemorrhagic strokes on baseline CT scan 2. History of hepatic failure 3. History of chronic kidney disease (creatinine clearance <30) 4. Stroke mimickers |
| Date of first enrolment | 24/05/2024 |
| Date of final enrolment | 22/05/2025 |
Locations
Countries of recruitment
- Philippines
Study participating centres
Baguio City
2600
Philippines
Quezon City
1100
Philippines
Sponsor information
Hospital/treatment centre
Gov Pack Road
Baguio City
2600
Philippines
| Phone | +63 (0)74 661 7910 |
|---|---|
| rec@bghmc.doh.gov.ph |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 22/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
01/07/2025: Study's existence confirmed by BGHMC Research Ethics Committee.
