A new analysis in JAMA Neurology suggests that treatment with clopidogrel plus aspirin after transient ischaemic attack (TIA) or minor acute ischaemic stroke (AIS) increases the risk of major haemorrhage over aspirin alone, although the risk is low.
Researchers performed a secondary analysis of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial which randomised patients in 269 sites worldwide to receive clopidogrel (600 mg loading dose on day one, followed by 75 mg daily for days 2-90) or placebo. All patients also received open-label aspirin 50-325 mg/d.
In the as-treated analyses (4,819 patients), major haemorrhage occurred in 21 patients receiving clopidogrel plus aspirin and six receiving aspirin alone (hazard ratio [HR] 3.57; 95% CI 1.44-8.85; number needed to harm, 159). There were four fatal haemorrhages—three in the clopidogrel plus aspirin group and one in the aspirin alone group—and there were seven intracranial haemorrhages: five in the clopidogrel plus aspirin group and two in the aspirin plus placebo group. The most common location of major haemorrhages was the gastrointestinal tract.
The authors estimated that for every 1,000 patients treated, adding clopidogrel might prevent about 15 major ischaemic events and cause five more major haemorrhages.