Efficacy of Tenecteplase Administered Between 4.5 and 24 Hours Post-Ischemic Stroke Onset
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on August 14th, 2024
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Thrombolytic therapy with plasminogen activators such as alteplase and tenecteplase is recommended within 4.5 hours of ischemic stroke symptom onset. However, many ischemic stroke cases reach the hospital after this window. While alteplase remains highly effective when administered within the first 9 hours, the effectiveness of tenecteplase beyond 4.5 hours is less understood. Therefore, the National Natural Science Foundation of China funded a study to evaluate the efficacy of tenecteplase when administered between 4.5 and 24 hours after ischemic stroke onset.
The clinical study included 516 patients, with an average age of around 67 years, who had been hospitalized for ischemic stroke with onset between 4.5 and 24 hours prior. Baseline brain volume with blood flow reduced by 30% was measured using CT scans and averaged affected region has an approximate volume of 120 mL. The 6-point modified Rankin scale was used to assess baseline disability, with over 85% of participants having the least severe score of 0, and the remaining participants scoring 1. Participants were randomly assigned to receive either standard therapy based on the physician’s discretion or an intravenous bolus of tenecteplase at 0.25 mg per kilogram of body weight. Health outcomes assessed 90 days post-treatment indicated that tenecteplase administration between 4.5 and 24 hours post-ischemic stroke onset resulted in better outcomes, defined by the percentage of patients with a modified Rankin scale score of 0 or 1. Additionally, tenecteplase was associated with significant neurological improvement within the first three days and increased reperfusion within 24 hours. Both groups had similar mortality rates; however, 3% of the tenecteplase-treated group experienced intracranial hemorrhage, compared to 0.8% in the standard therapy group.
The clinical study included 516 patients, with an average age of around 67 years, who had been hospitalized for ischemic stroke with onset between 4.5 and 24 hours prior. Baseline brain volume with blood flow reduced by 30% was measured using CT scans and averaged affected region has an approximate volume of 120 mL. The 6-point modified Rankin scale was used to assess baseline disability, with over 85% of participants having the least severe score of 0, and the remaining participants scoring 1. Participants were randomly assigned to receive either standard therapy based on the physician’s discretion or an intravenous bolus of tenecteplase at 0.25 mg per kilogram of body weight. Health outcomes assessed 90 days post-treatment indicated that tenecteplase administration between 4.5 and 24 hours post-ischemic stroke onset resulted in better outcomes, defined by the percentage of patients with a modified Rankin scale score of 0 or 1. Additionally, tenecteplase was associated with significant neurological improvement within the first three days and increased reperfusion within 24 hours. Both groups had similar mortality rates; however, 3% of the tenecteplase-treated group experienced intracranial hemorrhage, compared to 0.8% in the standard therapy group.