The HOPE trial, presented at the International Stroke Conference (ISC) 2025 on February 7, has unveiled promising data regarding the treatment of acute ischemic stroke. Conducted to assess the efficacy and safety of intravenous alteplase, the trial focused on patients treated up to 24 hours after symptom onset. This study included 372 stroke patients who were identified as having salvageable brain tissue through CT perfusion imaging.
The primary endpoint of the HOPE trial was to achieve a favorable outcome, defined as a modified Rankin scale score of 0-1 at 90 days. Results demonstrated that administering intravenous (IV) alteplase between 4.5 and 24.0 hours post-stroke onset led to a higher proportion of patients experiencing a nondisabled functional outcome compared to standard medical treatment. Specifically, 40.3% of patients in the alteplase group achieved favorable outcomes, compared to just 26.3% in the control group.
The relative risk of achieving a favorable outcome in the alteplase group was calculated at 1.52 (95% CI, 1.14-2.02; P = .004), indicating a significant improvement over the control group. Importantly, the trial found no increase in mortality rates, with 10.8% of patients in both groups deceased by 90 days. The open-label design of the trial featured outcome assessments conducted by evaluators blinded to treatment assignments.
Min Lou, MD, from the Second Affiliated Hospital of Zhejiang University's School of Medicine in Hangzhou, China, led the trial. Dr. Lou emphasized that these findings provide substantial evidence supporting thrombolysis benefits for select acute ischemic stroke patients up to 24 hours after symptom onset.
"Our results add to other recent data that support extending the therapeutic window for IV thrombolysis in acute ischemic stroke patients if endovascular thrombectomy is not available or indicated," – Min Lou, MD
The HOPE trial's results hold the potential to broaden treatment eligibility for millions globally, particularly in regions lacking access to endovascular thrombectomy. The study's less restrictive enrollment criteria included both large vessel and distal occlusion stroke patients and employed more flexible mismatch criteria for defining salvageable brain tissue.
"We believe these findings mean more people may return to normal or near-normal lives after a stroke, even if they receive treatment later than originally thought beneficial," – Min Lou, MD
However, it is important to note that these findings may not be generalizable to patients with large vessel occlusion who present directly to thrombectomy-capable centers or other populations outside China. Despite this limitation, the trial's design and execution provide valuable insights.
"This method of treatment could become the new standard, especially in hospitals that use CT perfusion imaging. This could extend treatment eligibility to millions more patients across the globe, particularly in regions that lack access to endovascular thrombectomy," – Min Lou, MD
The HOPE trial was sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Its results are consistent with previous studies like the EXTEND trial, which also showed a benefit of alteplase up to 9 hours using a similar approach.
"We have seen in previous studies that if we select the right patients with advanced imaging techniques then IV thrombolysis can show benefits in the later time window. This is one more step in that story. But these studies have been done predominantly in Asian patients, and it would be good to see more data in different populations. There will be more trials coming on this in the next few years." – Lauren Sansing, MD, Yale University
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