Between Dec 10, 2019, and Jan 25, 2022, 1,600 patients were enrolled and randomly assigned to tenecteplase (n=816) or alteplase (n=784), of whom 1577 were included in the intention-to-treat (ITT) population (n=806 tenecteplase; n=771 alteplase).

The median age was 74 years (IQR 63–83), 755 (47·9%) of 1,577 patients were female and 822 (52·1%) were male.

As of data cutoff (Jan 21, 2022), 296 (36·9%) of 802 patients in the tenecteplase group and 266 (34·8%) of 765 in the alteplase group had an mRS score of 0–1 at 90–120 days (unadjusted risk difference 2·1% [95% CI – 2·6 to 6·9], meeting the prespecified non-inferiority threshold).

In safety analyses, 27 (3·4%) of 800 patients in the tenecteplase group and 24 (3·2%) of 763 in the alteplase group had 24 h symptomatic intracerebral haemorrhage and 122 (15·3%) of 796 and 117 (15·4%) of 763 died within 90 days of starting treatment.

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