TOPLINE:
Dual antiplatelet therapy (DAPT) with clopidogrel-aspirin given within 72 hours of a mild ischemic stroke or a high-risk transient ischemic attack (TIA) shows a greater risk reduction for new stroke than aspirin alone, although with a higher bleeding risk.
METHODOLOGY:
- The INSPIRES, a double-blind, placebo-controlled trial, involved patients with mild ischemic stroke or high-risk TIA of presumed atherosclerotic cause who had not undergone thrombolysis or thrombectomy.
- A total of 6100 patients were randomly assigned to receive clopidogrel plus aspirin or matching clopidogrel placebo plus aspirin within 72 hours after symptom onset.
- The occurrence of any new stroke (ischemic or hemorrhagic) within 90 days was the primary efficacy outcome.
- The primary safety outcome was moderate to severe bleeding, also assessed within 90 days.
- Within 24 hours of symptom onset, 12.8% of patients were assigned to each treatment group, and the remaining 87.2% were assigned within the time window of 24-72 hours.
- The occurrence of a new stroke event at 90 days was 2 percentage points lower with clopidogrel plus aspirin vs aspirin alone (7.3% vs 9.2%; marginal estimated hazard ratio [HR], 0.79; P =.008).
- The risk of a composite cardiovascular event and ischemic stroke were also 20%-25% lower with aspirin-clopidogrel combo vs aspirin alone.
- Moderate to severe bleeding was low in both groups (<1%), but the risk was double in patients who received DAPT vs aspirin alone (HR, 2.08; P =.03).
In an accompanying editorial, Anthony S. Kim, MD from the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, commented, "The current trial provides evidence to support expanding the time window for dual antiplatelet therapy to 72 hours." He also warned against administering DAPT to "patients with heightened bleeding risks, such as those with a history of cerebral or systemic hemorrhage."
SOURCE:
Yilong Wang, MD, PhD, who held positions in the Department of Neurology, Beijing Tiantan Hospital, and several other institutions, was the corresponding author of this study. This study was published online on December 28 in the New England Journal of Medicine.
LIMITATIONS:
- Patients with stroke of presumed cardioembolic origin, those with moderate or severe stroke, and those who had undergone thrombolysis or thrombectomy were excluded from this study.
- Of the enrolled participants, 98.5% belonged to the Han Chinese ethnic group.
DISCLOSURES:
This study was supported by grants from the National Natural Science Foundation of China, the National Key R&D Program of China, and other sources. Some authors declared receiving grants or contracts or serving as consultants in various sources.
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