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BMJ 2012; 345 doi: (Published 06 September 2012) Cite this as: BMJ 2012;345:e5904

Adding clopidogrel to aspirin after lacunar stroke does more harm than good

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Although a previous study found that dual antiplatelet treatment with aspirin and clopidogrel helps prevent recurrent stroke in people with atrial fibrillation whose first stroke was caused by thromboembolism, this doesn’t seem to hold true for people with lacunar infarctions. This subtype of ischaemic stroke usually occurs because of disease in the small brain arteries, rather than thromboembolism.

The trial comprised 3020 people with lacunar stroke treated in participating centres across the Americas and Spain. All participants received 325 mg of aspirin each day; 1503 patients were also randomised to receive placebo and 1517 to receive 75 mg of clopidogrel daily.

Dual antiplatelet treatment did not prevent stroke during an average follow-up of 3.4 years. The primary outcome (any stroke: ischaemic or haemorrhagic) was seen in 138 people taking aspirin alone and in 125 people receiving dual treatment (2.7% v 2.5% per year; hazard ratio 0.92, 95% CI 0.72 to 1.16). In this factorial trial, participants were also randomised to control of hypertension, with systolic blood pressure targets of less than 130 mm Hg or 130-149 mm Hg, but this had no effect on the results (hazard ratio 1.01, 0.71 to 1.45 and 0.84, 0.61 to 1.17, respectively).

The risk of major bleeding was almost doubled with dual treatment (56 patients (1.1% per year) with aspirin alone v 105 (2.1%) with clopidogrel). However, the increase wasn’t significant for intracranial bleeding (1.52, 0.79 to 2.93) or for fatal intracranial bleeding (1.78, 0.52 to 6.07). Two patients assigned dual treatment died of extracranial bleeding, but this wasn’t enough to explain the excess deaths of any cause seen with dual treatment (113/1517 v 77/1503 with aspirin alone; 1.52, 1.14 to 2.04).

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