Reteplase is NOT Recommended for Acute Ischemic Stroke
Reteplase is not approved or recommended for acute ischemic stroke treatment; alteplase remains the only approved thrombolytic agent for this indication. 1, 2
Standard Thrombolytic Dosing for Acute Ischemic Stroke
The established treatment for acute ischemic stroke is alteplase 0.9 mg/kg (maximum 90 mg total dose), administered as 10% intravenous bolus over 1 minute, followed by 90% as continuous infusion over 60 minutes. 1, 2
Key Points About Alteplase Administration:
- Dosing is weight-based up to 100 kg maximum (not the flat dosing used for myocardial infarction) 1, 2
- Must be initiated within 3-4.5 hours of symptom onset 1
- Target door-to-needle time is less than 60 minutes in 90% of cases, with median of 30 minutes 1, 2
Why Reteplase is Not Used for Stroke
Approved Indication for Reteplase:
Reteplase is FDA-approved only for acute myocardial infarction, where it is given as two 10-unit bolus doses 30 minutes apart. 1, 3, 4 This is fundamentally different from stroke treatment requirements.
Limited Stroke Evidence:
- Reteplase has been studied in acute ischemic stroke only in small phase 1 and phase 2 trials as an investigational agent 5, 6
- One 2024 trial (RAISE) showed potential efficacy but also demonstrated higher rates of any intracranial hemorrhage at 90 days (7.7% vs 4.9%) and more adverse events (91.6% vs 82.4%) compared to alteplase 7
- These studies used experimental dosing regimens (12+12 mg or 18+18 mg as double boluses) that are not approved for clinical use 7, 6
Critical Pitfall to Avoid:
Do not confuse reteplase dosing for myocardial infarction (10 U + 10 U) with stroke treatment. 1 The myocardial infarction protocol is completely inappropriate for stroke patients and could result in serious harm.
Current Guideline Recommendations
Major stroke guidelines from the American Heart Association/American Stroke Association, European Society of Cardiology, and Canadian Stroke Best Practice all specify:
- Alteplase is the only approved thrombolytic for acute ischemic stroke 1, 2
- No other thrombolytic agents are currently recommended outside of clinical trials 1, 2
- Reteplase appears only in historical myocardial infarction guidelines, not stroke guidelines 1
When Considering Alternative Thrombolytics:
If alteplase is unavailable or there are concerns about its use, endovascular thrombectomy should be considered for eligible patients with large vessel occlusion rather than substituting an unapproved thrombolytic agent. 1, 2
Practical Clinical Approach
For acute ischemic stroke within 4.5 hours:
- Use alteplase 0.9 mg/kg (max 90 mg) as the standard thrombolytic 1, 2
- Administer 10% as bolus over 1 minute, then 90% over 60 minutes 1, 2
- Ensure blood pressure is <185/110 mmHg before and during administration 1, 2
- Monitor for symptomatic intracranial hemorrhage as the primary safety concern 1, 2
Reteplase should only be considered: