ISC 2025 | Treatment with intravenous alteplase in AIS with onset time between 4.5 and 24 hours

I would like to introduce a little bit of background. Thrombolysis has a very strict time window within 4.5 hours previously. So the patient who could arrive within the time window is limited. So if we could extend the time window to 9 hours, so the beneficial effects of patients would grow more. And if we could extend to 24 hours, so the patient who’s potentially benefited from the treatment could expand more. So this is the reason why we tried to do the clinical trial to explore whether we treated the patient within 4.5 to 24 hours could still benefit from the treatment based on the imaging identified criteria. So this is what we try to do in our trials. This trial is actually a multicenter, open-label, randomized, outcome-blinded randomized clinical trial. And it has enrolled finally 372 patients in 26 sites around China. And so the patients were randomized to two groups. The first is alteplase treatment groups, and another is the patient who received standard treatment. Finally, we compared the outcome. The percentage of the patient who finally achieved a modified Rankin score of 0 to 1 and finding that the percentage of patients achieved a modified Rankin score of 0 to 1 is about 40% versus 26% in the standard treatment groups. So the treatment effect is showing that thrombolysis with alteplase increased the likelihood of patients who could finally achieve non-disabled outcome. This is the main primary outcome. And also there are other secondary outcomes. Some of them also have positive results. And also concerning the safety outcome, we found that the rate of symptomatic intracranial hemorrhage was higher in the groups treated with thrombolysis compared with the standard treatment group. However, the mortality rate was the same between two groups. So that means that the increase of the symptomatic intracranial hemorrhage did not lead to the increase of the deaths within 90 days. So this is the safety outcome. So finally, our findings support the extension of time window to 24 hours in patients who had the salvageable tissue identified from the perfusion imaging. So this is our final result. We thought it was very useful to extend the time window because more and more patients would still get the chance to be treated with thrombolysis even though they arrived in the hospital later. So this is different from the previous situation. And in the future, we would like to expand time window further, maybe to three days or seven days. So based on the same criteria identified from the perfusion imaging, but we know that this might be more difficult, and you’ll see whether the result will be okay or not.

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