BACKGROUND AND AIMS: Antiplatelet treatment is recommended to start 24 h after intravenous thrombolysis due to concerns about haemorrhagic transformation. This study aimed to investigate the potential benefit of early antiplatelet after intravenous thrombolysis in minor stroke.
METHODS: A multicentre, double-blind, randomized trial was conducted in China between 7 August 2022 and 1 August 2024, to evaluate the efficacy and safety of early antiplatelet in acute ischaemic stroke patients presenting with mild neurological deficits, as indicated by a National Institutes of Health Stroke Scale (NIHSS) score of 0-5, who received intravenous thrombolysis. Patients were randomly assigned to receive either clopidogrel and aspirin or placebo within 6 h after intravenous thrombolysis. The primary endpoint was an excellent functional outcome at 90 days, indicated by a modified Rankin Scale (mRS) score of 0-1. Statistical analysis was based on a modified intention-to-treat population. Symptomatic intracranial haemorrhage, any intracranial haemorrhage, and major systemic bleeding were safety endpoints.
RESULTS: The primary endpoint was not met in this study. Of the randomly assigned 1022 patients, 995 patients were included in the modified intention-to-treat analysis (503 with early antiplatelet treatment and 492 with placebo). The primary endpoint occurred in 89.7% (451/503) of patients receiving early antiplatelet vs 89.6% (441/492) of those receiving placebo with no significant difference (odds ratio 1.00, 95% confidence interval .67-1.51, P = .99). Similar safety profiles were found between the two groups.
CONCLUSIONS: Among Chinese patients with acute minor ischaemic stroke who received intravenous thrombolysis, early antiplatelet treatment with clopidogrel plus aspirin was safe but did not improve already excellent functional outcome (mRS 0-1) at 90 days.
| Discipline Area | Score |
|---|---|
| Emergency Medicine |  |
| Neurology |  |
This multicenter RCT evaluated early antiplatelet therapy in acute ischemic stroke in patients with mild deficits, defined as NIHSS 0-5, who received thrombolysis. The intervention included clopidogrel and aspirin versus placebo within 6 hours of thrombolysis. There was no difference in excellent functional outcome at 90 days, as well as no difference in safety profiles, including intracerebral hemorrhage. Based on these results, early antiplatelet therapy following thrombolysis requires further study and at this time should not be used routinely.
This double-blind randomized trial evaluated the efficacy and safety of early (within 6 hours of thrombolysis) antiplatelet therapy with aspirin and clopidogrel together compared with placebo in patients with ischemic stroke presenting with mild neurological deficits (a National Institutes of Health Stroke Scale [NIHSS] score of <6) who received thrombolysis. The primary endpoint was a good neurologic outcome at 90 days, indicated by a modified Rankin Scale score of 0–1. An appropriate power calculation suggested needing a total of 1022 patients; 995 were enrolled. There was no statistically significant difference between the 2 groups in the proportion with the primary endpoint (89.7% and 89.6% in the treatment and placebo groups, respectively) nor in the safety endpoints, including mortality and symptomatic intracranial hemorrhage.
This trial included Chinese participants only, so has limited external validity. There was no benefit shwon from early dual antiplatelet therapy after thrombolysis in minor stroke, even though it does not increase bleeding. We are awaiting the results of other ongoing studies, but we should consider a trial with dual antiplatelet therapy in moderate-to-severe stroke also evaluating large-vessel occlusion.
