Tenecteplase extends Window for Additional Stroke Treatment up to 24 Hrs

A one-hour infusion of alteplase is the standard treatment for a clot-caused (ischemic) stroke, administered within 4.5 hours of first stroke symptoms. Alteplase dissolves blood clots that are blocking arteries supplying oxygen-rich blood to the lungs or brain and has been FDA-approved for the immediate treatment of ischemic stroke since 1996.

Tenecteplase is a novel anti-thrombosis medication in which studies are ongoing to determine its safety, efficacy and treatment parameters for ischemic stroke. Previous studies of Tenecteplase to treat acute ischemic stroke patients found it may be non-inferior to alteplase and may be superior for treating large-vessel strokes.

Dr Xin Cheng and his team conducted a Phase 2a study to evaluate the safety and efficacy of tenecteplase to treat patients with large-vessel strokes. In this randomised study, the researchers included 86 patients with ischemic strokes treated at 13 different hospitals in China. They were randomly assigned to two groups:

♦ 43 patients (average age of 68 years; 58.1% male) received a lower (0.25 mg/kg) dose of tenecteplase; and

♦ 43 patients (average age of 67 years; 72.1% male) received a higher (0.32 mg/kg) dose of tenecteplase.

In addition to tenecteplase, some patients underwent endovascular therapy (thrombectomy) to mechanically remove a clot, at the discretion of the treating physician. The outcome assessed was a major restoration of blood flow without symptomatic brain bleeding 24-48 hours after treatment. They determined if more than 7 of 43 patients met the positive outcome criteria, that intervention dose of tenecteplase would be deemed of sufficient promise to warrant further study

Key findings of the study:

• At the lower dose of tenecteplase, the researchers observed that 14 of 43 patients (32.6%) achieved the designated positive outcome criteria.
• At the higher dose of tenecteplase, they noted that 10 of 43 patients (23.3%) achieved the designated positive outcome criteria.
• Upon 3 months follow-up, they found that more than half (53.5%) of the patients were no more than slightly disabled, not able to carry out all previous activities but did not require daily assistance, and 38.4% of the participants either had no significant symptoms of residual neurological deficits or had mild symptoms but were able to return to pre-stroke activities of daily living.

The authors concluded, "In our study, tenecteplase seems to be quite effective and safe in patients who do not need endovascular therapy. More research is needed to understand why tenecteplase was less effective in restoring blood flow and more likely to result in symptomatic brain bleeding among those who had endovascular therapy".

For further information:

Cheng X. Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection. Presented at: ASA ISC 2022. February 10, 2022