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Updated: Jun 23, 2025

Prehospital Thrombolysis: A Manual from Berlin
Published on: November 26, 2013
Reteplase versus Alteplase for Acute Ischemic Stroke
Shuya Li1, Hong-Qiu Gu1, Hao Li1
1From the Departments of Neurology (S.L., H.L., X.W., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang) and Clinical Trial Center (S.L., H.L., X.W., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang), and the China National Clinical Research Center for Neurologic Diseases (S.L., H.-Q.G., H.L., X.W., A.J., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang), Beijing Tiantan Hospital, Capital Medical University, Beijing, the Emergency Department, Linfen Central Hospital, Linfen (S.G.), the Department of Neurology, Ke shi ke teng Banner Traditional Chinese Medicine and Mongolian Medical Hospital, Chifeng (G.L.), the Department of Neurology, Linyi People's Hospital, Linyi (F.C.), the Department of Neurology, Xianyang Hospital of Yan'an University, Xianyang (W.W.), and the Department of Neurology, Halison International Peace Hospital, Hengshui (Y. Wei) - all in China.
Reteplase demonstrated superior efficacy in achieving excellent functional outcomes for acute ischemic stroke patients compared to alteplase. While reteplase showed improved results, careful monitoring for adverse events is crucial.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Pharmacology
Background:
- Alteplase is the current standard for early reperfusion therapy in acute ischemic stroke.
- There is a need for alternative thrombolytic agents with comparable or improved efficacy and safety profiles.
- The comparative effectiveness and safety of reteplase versus alteplase in acute ischemic stroke remain incompletely understood.
Purpose of the Study:
- To compare the efficacy and safety of reteplase with alteplase in patients experiencing acute ischemic stroke.
- To evaluate the rate of excellent functional outcomes at 90 days post-stroke.
- To assess the incidence of symptomatic intracranial hemorrhage within 36 hours of symptom onset.
Main Methods:
- A randomized controlled trial comparing intravenous reteplase (18 mg bolus followed by 18 mg 30 minutes later) with intravenous alteplase (0.9 mg/kg, max 90 mg).
- Patients with ischemic stroke were enrolled within 4.5 hours of symptom onset and randomized 1:1.
- Primary efficacy endpoint: excellent functional outcome (modified Rankin scale score 0 or 1 at 90 days). Primary safety endpoint: symptomatic intracranial hemorrhage within 36 hours.
Main Results:
- An excellent functional outcome was achieved in 79.5% of patients receiving reteplase versus 70.4% receiving alteplase (risk ratio, 1.13; P=0.002 for superiority).
- Symptomatic intracranial hemorrhage occurred in 2.4% of the reteplase group and 2.0% of the alteplase group (risk ratio, 1.21).
- The overall incidence of intracranial hemorrhage at 90 days (7.7% vs. 4.9%) and adverse events (91.6% vs. 82.4%) was higher with reteplase.
Conclusions:
- Reteplase was associated with a higher likelihood of excellent functional outcomes compared to alteplase in patients with acute ischemic stroke treated within 4.5 hours.
- Despite improved functional outcomes, the study noted a higher incidence of intracranial hemorrhage and overall adverse events with reteplase.
- Further research may be warranted to optimize reteplase use or mitigate associated risks in acute ischemic stroke management.

