2025-08-11 浙江大学(ZJU)
<関連情報>
- https://www.zju.edu.cn/english/2025/0811/c19573a3074168/page.htm
- https://jamanetwork.com/journals/jama/article-abstract/2837438
急性虚血性脳卒中に対するアルテプラーゼ(発症4.5～24時間) HOPE無作為化臨床試験 Alteplase for Acute Ischemic Stroke at 4.5 to 24 Hours The HOPE Randomized Clinical Trial
Ying Zhou, PhD; Yaode He, MD; Bruce C. V. Campbell, PhD;et al
Journal of the American Medical Association Published:August 7, 2025
DOI: 10.1001/jama.2025.12063
Key Points
Question Does intravenous alteplase administered 4.5 to 24 hours after acute ischemic stroke onset improve outcomes in patients with salvageable brain tissue and no initial plan for thrombectomy?
Findings In this randomized clinical trial of 372 patients, 40% receiving alteplase achieved functional independence at 90 days vs 26% with standard care, a statistically significant difference.
Meaning In patients with salvageable brain tissue identified by perfusion imaging who did not initially receive thrombectomy, alteplase given 4.5 to 24 hours after acute ischemic stroke onset may improve functional outcomes.
Abstract
Importance The safety and efficacy of intravenous thrombolytics beyond 4.5 hours after ischemic stroke onset remain inadequately studied.
Objective To evaluate the safety and efficacy of intravenous alteplase administered 4.5 to 24 hours after stroke onset in patients with salvageable brain tissue, regardless of the presence of large vessel occlusion.
Design, Setting, and Participants This randomized, open-label, blinded end-point trial was conducted at 26 stroke centers across China. A total of 372 patients with acute ischemic stroke and salvageable brain tissue identified by perfusion imaging were enrolled between June 21, 2021, and June 30, 2024 (final follow-up October 2, 2024). Eligibility criteria included stroke onset (or the midpoint between last known well and symptom recognition if onset was unknown) of 4.5 to 24 hours prior to presentation, and no initial plan for endovascular thrombectomy. Data were analyzed from December 2024 to February 2025.
Interventions Patients were randomly assigned (1:1) using a minimization algorithm to receive intravenous alteplase (0.9 mg/kg; maximum dose, 90 mg; n = 186) or standard medical treatment (n = 186).
Main Outcomes and Measures The primary efficacy outcome was functional independence, defined as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage within 36 hours and all-cause mortality within 90 days.
Results Among 372 patients who were enrolled (median [IQR] age, 72 [64-80] years; 160 [43%] women), all completed the trial. The primary outcome occurred in 75 of 186 patients (40%) in the alteplase group and 49 of 186 (26%) in the control group (adjusted risk ratio, 1.52 [95% CI, 1.14-2.02]; P = .004; unadjusted risk difference, 13.98% [95% CI, 4.50%-23.45%]). The incidence of symptomatic intracranial hemorrhage was higher with alteplase at 3.8% compared with 0.51% with standard treatment (adjusted risk ratio, 7.34 [95% CI, 1.54-34.84]; P = .01; unadjusted risk difference, 3.23% [0.28%-6.19%]), and mortality was 11% in both groups (adjusted risk ratio, 0.91 [95% CI, 0.52-1.62]; P = .76; unadjusted risk difference, 0% [95% CI, -6.30% to 6.30%]).
Conclusions and Relevance In patients with acute ischemic stroke with salvageable brain tissue identified by perfusion imaging who did not initially receive thrombectomy, intravenous alteplase administered 4.5 to 24 hours after onset provided functional benefit, despite an increase in symptomatic intracranial hemorrhage.
Trial Registration ClinicalTrials.gov Identifier: NCT04879615
