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Trials testing rt‐PA showed a significant reduction in death or dependency with treatment up to six hours (OR 0.84, 95% CI 0.77 to 0.93, P = 0.0006 8 trials, 6729 participants) with significant heterogeneity treatment within three hours was more beneficial (OR 0.65, 95% CI 0.54 to 0.80, P < 0.0001 6 trials, 1779 participants) without heterogeneity. Contemporaneous antithrombotic drugs increased the risk of death. There was heterogeneity between the trials. Treatment within three hours of stroke was more effective in reducing death or dependency (OR 0.66, 95% CI 0.56 to 0.79) without any increase in death (OR 0.99, 95% CI 0.82 to 1.21 11 trials, 2187 participants). Early death after thrombolysis was mostly attributable to intracranial haemorrhage. Thrombolytic therapy increased the risk of symptomatic intracranial haemorrhage (OR 3.75, 95% CI 3.11 to 4.51), early death (OR 1.69, 95% CI 1.44 to 1.98 13 trials, 7458 participants) and death by three to six months after stroke (OR 1.18, 95% CI 1.06 to 1.30).

Thrombolytic therapy, mostly administered up to six hours after ischaemic stroke, significantly reduced the proportion of participants who were dead or dependent (modified Rankin 3 to 6) at three to six months after stroke (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.78 to 0.93). More than 50% of trials fulfilled criteria for high‐grade concealment there were few losses to follow‐up for the main outcomes. Trials published more recently utilised computerised randomisation, so there are less likely to be baseline imbalances than in previous versions of the review. In earlier studies very few of the participants (0.5%) were aged over 80 years in this update, 16% of participants are over 80 years of age due to the inclusion of IST‐3 (53% of participants in this trial were aged over 80 years). About 44% of the trials (about 70% of the participants) were testing intravenous rt‐PA.

Most data come from trials that started treatment up to six hours after stroke. Four trials used intra‐arterial administration, while the rest used the intravenous route. We included 27 trials, involving 10,187 participants, testing urokinase, streptokinase, rt‐PA, recombinant pro‐urokinase or desmoteplase.

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