SPS3 Clopidogrel-ASA
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
63.0% male
N = 3020
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 ICH, 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
2.5
2.7
2.7 % / y
2.0 % / y
1.4 % / y
0.7 % / y
0.0 % / y
Clopidogrel
Placebo
No significant
difference ↔
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.
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