While the rates of death were identical at 10.8% in both treatment groups, the risk of brain bleeding was higher for those receiving alteplase at 3.8% compared to 0.5% in the control group.
However, the study's limitations include potential bias from both participants and researchers being aware of treatment allocation, and the results may not be applicable to populations outside of China.
Dr. Lou emphasized the significance of these findings for stroke patients worldwide who may miss the current approved time windows for treatment, suggesting the need to explore other clot-dissolving medications like tenecteplase for late treatment.
A recent study presented at the American Stroke Association's International Stroke Conference 2025 revealed that alteplase, a clot-dissolving medication, significantly improves recovery for stroke patients when administered up to 24 hours after symptoms begin.
Conducted across 26 stroke centers in China, the trial involved 372 stroke patients, with an average age of 72 years and 43% of participants being women.
The study utilized CT perfusion imaging to confirm salvageable brain tissue, allowing treatment beyond the previously established time limits of 4.5 hours in China and 3 to 4.5 hours in the U.S.
These findings have implications for extending treatment eligibility to millions of stroke patients globally who cannot access care within standard time frames.
Participants were randomly divided into two groups: one receiving alteplase and the other receiving standard care with antiplatelet therapy based on Chinese guidelines.
Functional recovery was evaluated 90 days post-treatment, revealing that 40% of patients treated with alteplase experienced little to no disability, compared to 26% in the standard care group, indicating a 54% higher chance of recovery.
Dr. Min Lou, the principal investigator, suggested that these findings could lead to a new standard of care, particularly in hospitals utilizing CT perfusion imaging.
In the U.S., alteplase is approved for use within three hours of symptom onset, with a recommendation for up to 4.5 hours for select patients, but this new research suggests efficacy may extend even further, up to 9 hours post-stroke onset.
The primary outcome was measured using the modified Rankin scale, assessing disability at 90 days post-treatment.
