INSPIRES (statin therapy)
Trial question
What is the role of immediate intensive statin therapy in patients with acute mild ischemic stroke or TIA from atherosclerosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 6100
6100 patients (2185 female, 3915 male).
Inclusion criteria: patients aged 35-80 years with mild ischemic stroke or high-risk TIA of presumed atherosclerosis within 72 hours of symptom onset.
Key exclusion criteria: TIA or ischemic stroke of presumed cardioembolic or other determined etiology; moderate-to-severe prestroke disability; receipt of intravenous thrombolysis or endovascular therapy after onset; receipt of fibrinogen therapy, anticoagulation therapy, or antiplatelet therapy except for clopidogrel and aspirin after onset.
Interventions
N=3050 immediate intensive statin therapy (atorvastatin 80 mg daily on days 1-21, 40 mg daily on days 22-90).
N=3050 delayed intensive statin therapy (placebo for days 1-3, followed by placebo and atorvastatin 40 mg daily on days 4-21 and then atorvastatin 40 mg daily on days 22-90).
Primary outcome
Rate of new stroke within 90 days
8.1%
8.4%
8.4 %
6.3 %
4.2 %
2.1 %
0.0 %
Immediate intensive statin
therapy
Delayed intensive statin
therapy
No significant
difference ↔
No significant difference in the rate of new stroke within 90 days (8.1% vs. 8.4%; HR 0.95, 95% CI 0.8 to 1.13).
Secondary outcomes
Significant decrease in poor functional outcome (9.8% vs. 11.4%; OR 0.83, 95% CI 0.71 to 0.98).
No significant difference in stroke, MI, or vascular death (8.2% vs. 8.6%; HR 0.96, 96% CI 0.81 to 1.14).
Safety outcomes
No significant difference in moderate-to-severe bleeding.
Significant difference in overall adverse event (22.7% vs. 19.8%).
Conclusion
In patients aged 35-80 years with mild ischemic stroke or high-risk TIA of presumed atherosclerosis within 72 hours of symptom onset, immediate intensive statin therapy was not superior to delayed intensive statin therapy with respect to the rate of new stroke within 90 days.
Reference
Ying Gao, Lingling Jiang, Yuesong Pan et al. Immediate- or Delayed-Intensive Statin in Acute Cerebral Ischemia: The INSPIRES Randomized Clinical Trial. JAMA Neurol. 2024 May 28:e241433.
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