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Clopidogrel Plus Aspirin vs Aspirin Alone in Patients With Acute Mild to Moderate Stroke: The ATAMIS Randomized
Hui-Sheng Chen1, Yu Cui1, Xin-Hong Wang1
1Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, China.
Insights
Dual antiplatelet therapy with clopidogrel plus aspirin reduced early neurologic deterioration in patients with mild to moderate ischemic stroke compared to aspirin alone. This dual therapy demonstrated a similar safety profile, suggesting it may be a superior treatment option.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Dual antiplatelet therapy (DAPT) is effective for secondary stroke prevention in transient ischemic attack and minor stroke.
- Evidence for DAPT's efficacy in mild to moderate ischemic stroke is limited.
- This study addresses the need for robust evidence in this patient population.
Purpose of the Study:
- To evaluate the superiority of DAPT (clopidogrel plus aspirin) versus single antiplatelet therapy (aspirin alone) in patients with mild to moderate ischemic stroke.
- To assess the impact on early neurologic deterioration.
- To compare safety profiles, specifically bleeding events.
Main Methods:
- A multicenter, open-label, blinded endpoint, randomized clinical trial.
- 3000 patients with acute mild to moderate ischemic stroke within 48 hours of onset were randomized.
- Interventions included clopidogrel plus aspirin versus aspirin alone.
Main Results:
- Early neurologic deterioration at 7 days occurred in 4.8% of the DAPT group versus 6.7% in the aspirin alone group (P=.03).
- The risk difference for early neurologic deterioration was -1.9% (95% CI, -3.6 to -0.2).
- Bleeding events were similar between the two treatment groups.
Conclusions:
- Dual antiplatelet therapy (clopidogrel plus aspirin) is superior to aspirin alone in reducing early neurologic deterioration in Chinese patients with acute mild to moderate ischemic stroke.
- DAPT demonstrated a similar safety profile to aspirin alone.
- These findings suggest DAPT may be a preferred treatment for acute mild to moderate ischemic stroke.
Importance:
Dual antiplatelet therapy has been demonstrated to be superior to single antiplatelet in reducing recurrent stroke among patients with transient ischemic attack or minor stroke, but robust evidence for its effect in patients with mild to moderate ischemic stroke is lacking.
Objective:
To evaluate whether dual antiplatelet therapy is superior to single antiplatelet among patients with mild to moderate ischemic stroke.
Design, Setting, And Participants:
This was a multicenter, open-label, blinded end point, randomized clinical trial conducted at 66 hospitals in China from December 20, 2016, through August 9, 2022. The date of final follow-up was October 30, 2022. The analysis was reported on March 12, 2023. Of 3065 patients with ischemic stroke, 3000 patients with acute mild to moderate stroke within 48 hours of symptom onset were enrolled, after excluding 65 patients who did not meet eligibility criteria or had no randomization outcome.
Interventions:
Within 48 hours after symptom onset, patients were randomly assigned to receive clopidogrel plus aspirin (n = 1541) or aspirin alone (n = 1459) in a 1:1 ratio.
Main Outcomes And Measures:
The primary end point was early neurologic deterioration at 7 days, defined as an increase of 2 or more points in National Institutes of Health Stroke Scale (NIHSS) score, but not as a result of cerebral hemorrhage, compared with baseline. The superiority of clopidogrel plus aspirin to aspirin alone was assessed based on a modified intention-to-treat population, which included all randomized participants with at least 1 efficacy evaluation regardless of treatment allocation. Bleeding events were safety end points.
Results:
Of the 3000 randomized patients, 1942 (64.6%) were men, the mean (SD) age was 65.9 (10.6) years, median (IQR) NIHSS score at admission was 5 (4-6), and 1830 (61.0%) had a stroke of undetermined cause. A total of 2915 patients were included in the modified intention-to-treat analysis. Early neurologic deterioration occurred in 72 of 1502 (4.8%) in the dual antiplatelet therapy group vs 95 of 1413 (6.7%) in the aspirin alone group (risk difference -1.9%; 95% CI, -3.6 to -0.2; P = .03). Similar bleeding events were found between 2 groups.
Conclusions And Relevance:
Among Chinese patients with acute mild to moderate ischemic stroke, clopidogrel plus aspirin was superior to aspirin alone with regard to reducing early neurologic deterioration at 7 days with similar safety profile. These findings indicate that dual antiplatelet therapy may be a superior choice to aspirin alone in treating patients with acute mild to moderate stroke.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02869009.
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