CHANCE
Trial question
What is the role of combination of clopidogrel with aspirin in patients with acute minor stroke or TIA?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 5170
5170 patients (1750 female, 3420 male).
Inclusion criteria: patients after the onset of minor ischemic stroke or high-risk TIA.
Key exclusion criteria: hemorrhage, VM, tumor, abscess, isolated sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness or vertigo without evidence of acute infarction on baseline CT or MRI of the head.
Interventions
N=2584 clopidogrel-aspirin (clopidogrel at an initial dose of 300 mg, followed by 75 mg per day for 90 days, plus aspirin at a dose of 75 mg per day for the first 21 days).
N=2586 aspirin alone (placebo plus aspirin 75 mg per day for 90 days).
Primary outcome
Stroke
8.2%
11.7%
11.7 %
8.8 %
5.8 %
2.9 %
0.0 %
Clopidogrel-aspirin
Aspirin
alone
Significant
decrease ▼
NNT = 28
Significant decrease in stroke (8.2% vs. 11.7%; HR 0.68, 95% CI 0.57 to 0.81).
Secondary outcomes
Significant decrease in vascular events (8.4% vs. 11.9%; HR 0.69, 95% CI 0.58 to 0.82).
Significant decrease in ischemic stroke (7.9% vs. 11.4%; HR 0.67, 95% CI 0.56 to 0.81).
No significant difference in hemorrhagic stroke (0.3% vs. 0.3%; HR 1.01, 95% CI 0.38 to 2.7).
Safety outcomes
No significant differences in adverse events (5.8% vs. 5.0%) and serious adverse events (1.0% vs. 0.8%) and moderate or severe hemorrhage (0.3% vs. 0.3%, p=0.73).
Significant differences in any bleeding (2.3% vs. 1.6%, p = 0.09).
Conclusion
In patients after the onset of minor ischemic stroke or high-risk TIA, clopidogrel-aspirin was superior to aspirin alone with respect to stroke.
Reference
Wang Y, Wang Y, Zhao X et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9.
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