6/29/23, 11:45 PM SPS3 Clopidogrel-ASA Pathway Feedback Search Clinical Topics Home Studies SPS3 Clopidogrel-ASA SPS3 Clopidogrel-ASA Disease Acute ischemic stroke Trial question What is the effect of combination of clopidogrel to aspirin in patients with recent lacunar stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 37.0% female N = 3020 63.0% male 3020 patients (1118 female, 1902 male) Inclusion criteria: patients with recent symptomatic lacunar infarcts identified by MRI Key exclusion criteria: MRI evidence of a recent or remote cortical infarct, a large subcortical infarct > 1.5 cm in diameter), intracerebral hemorrhage, disabling stroke, previous intracranial hemorrhage, or cortical ischemic stroke Interventions N=1517 clopidogrel (75 mg clopidogrel plus 325 mg aspirin daily) N=1503 placebo (placebo plus 325 mg aspirin daily) Primary outcome Incidence of recurrent stroke, at a mean follow-up of 3.4 years https://web.pathway.md/studies/recv7w8ocA4GfTvKG 1/2 6/29/23, 11:45 PM SPS3 Clopidogrel-ASA Pathway 2.7 % / y 2.7 2.5 2.0 % / y 1.4 % / y 0.7 % / y No significant difference 0.0 % / y Clopidogrel Placebo No significant difference in the incidence of recurrent stroke, at a mean follow-up of 3.4 years (2.5% / y vs. 2.7% / y; HR 0.92, 95% CI 0.72 to 1.16) Secondary outcomes Significant increase in the incidence of death from any cause (2.1% / y vs. 1.4% / y; HR 1.52, 95% CI 1.14 to 2.04) No significant difference in the incidence of recurrent ischemic stroke (2% / y vs. 2.4% / y; HR 0.82, 95% CI 0.63 to 1.09) No significant difference in the incidence of disabling or fatal stroke (0.84% / y vs. 0.78% / y; HR 1.06, 95% CI 0.69 to 1.64) Safety outcomes Significant differences in major hemorrhage (2.1% vs. 1.1% per year, p < 0.001; HR 1.97, 95% CI 1.41-2.71). Conclusion In patients with recent symptomatic lacunar infarcts identified by MRI, clopidogrel was not superior to placebo with respect to the incidence of recurrent stroke, at a mean follow-up of 3.4 years. Reference SPS Investigators, Benavente OR, Hart RG et al. Effects of clopidogrel added to aspirin in patients with recent lacunar stroke. N Engl J Med. 2012 Aug 30;367(9):817-25. Open reference URL https://web.pathway.md/studies/recv7w8ocA4GfTvKG 2/2