Cerebroprotin Has No Established Indication in Acute Ischemic Stroke
Cerebroprotin is not mentioned in any major stroke guidelines and has no evidence-based role in the management of acute ischemic stroke in adults or geriatric patients.
Evidence-Based Acute Stroke Management
The comprehensive American Heart Association/American Stroke Association guidelines for acute ischemic stroke management do not include cerebroprotin among recommended therapies 1. The 2018 AHA/ASA guidelines provide an exhaustive review of acute stroke interventions, and cerebroprotin is notably absent from all treatment recommendations 1.
Established Acute Stroke Therapies
Thrombolytic Therapy
- Intravenous alteplase (rtPA) at 0.9 mg/kg (maximum 90 mg) is the only FDA-approved pharmacological intervention for acute ischemic stroke within 3-4.5 hours of symptom onset 1, 2.
- The American College of Emergency Physicians recommends IV tPA should be offered to selected patients within 3 hours of symptom onset at institutions with appropriate systems in place (Level B recommendation) 1.
- For treatment beyond 3 hours but within 4.5 hours, evidence suggests clinicians should not use IV tPA (Grade 2A), and beyond 4.5 hours, IV tPA is not recommended (Grade 1A) 2.
Antiplatelet Therapy
- Aspirin 325 mg orally within 24-48 hours after stroke onset is the only recommended antiplatelet therapy for acute ischemic stroke (Class I, Level of Evidence A) 1.
- Aspirin should not be given within 24 hours of thrombolytic therapy (Class III, Level of Evidence A) 1.
- Clopidogrel alone or in combination with aspirin is not recommended for acute ischemic stroke treatment (Class III, Level of Evidence C) 1.
Therapies Without Evidence Support
Neuroprotective agents, including any compound marketed as "cerebroprotin," lack conclusive evidence for safety or efficacy in acute ischemic stroke 1. The AHA/ASA guidelines explicitly state that "no data are available to demonstrate the efficacy of a neuroprotective intervention as a complement to thrombolysis or other therapies to restore perfusion" 1.
Clinical Implications
If cerebroprotin is being considered or marketed as a neuroprotective agent, stroke treatment agent, or combination therapy:
- It should not be used outside of properly designed clinical trials (Class III recommendation) 1.
- Numerous neuroprotective medications have shown promise in experimental studies but produced disappointing or harmful results in clinical trials 1.
- Some neuroprotective agents have resulted in treated patients having poorer outcomes than controls or unacceptably high rates of adverse experiences 1.
Standard of Care
The evidence-based acute stroke management algorithm includes 1, 3:
- Immediate neuroimaging (CT within 25 minutes of ED arrival) 4
- Blood pressure management (maintain <185/110 mmHg for thrombolysis candidates; otherwise treat only if >220/120 mmHg) 1, 3
- Glucose control (treat hyperglycemia >155 mg/dL) 5
- Temperature management (antipyretics for temperature >37.5°C) 5
- Stroke unit care with organized systems 5
Any agent not included in these evidence-based guidelines, including cerebroprotin, should be considered investigational at best and potentially harmful until proven otherwise through rigorous clinical trials.