Effect of clopidogrel with aspirin on functional outcome in TIA or minor stroke
CHANCE substudy
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Abstract
Objective: We compared the effect of clopidogrel plus aspirin vs aspirin alone on functional outcome and quality of life in the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial of aspirin-clopidogrel vs aspirin alone after acute minor stroke or TIA.
Methods: Participants were assessed at 90 days for functional outcome using the modified Rankin Scale (mRS) and quality of life using the EuroQol-5 Dimension (EQ-5D). Poor functional outcome was defined as mRS score of 2–6 at 90 days and poor quality of life as EQ-5D index score of 0.5 or less.
Results: Poor functional outcome occurred in 254 patients (9.9%) in the clopidogrel-aspirin group, as compared with 299 (11.6%) in the aspirin group (p = 0.046). Poor quality of life occurred in 142 (5.5%) in the clopidogrel-aspirin group and in 175 (6.8%) in the aspirin group (p = 0.06). Disabling stroke at 90 days occurred in 166 (6.5%) in the clopidogrel-aspirin group and in 219 (8.5%) in the aspirin group (p = 0.01). In stratified analysis by subsequent stroke, there was no difference in 90-day functional outcome and quality of life between the 2 groups.
Conclusions: In patients with minor stroke or TIA, the combination of clopidogrel and aspirin appears to be superior to aspirin alone in improving the 90-day functional outcome, and this is consistent with a reduction in the rate of disabling stroke in the dual antiplatelet arm.
Classification of evidence: This study provides Class II evidence that for patients with acute minor stroke or TIA, clopidogrel plus aspirin compared to aspirin alone improves 90-day functional outcome (absolute reduction of poor outcome 1.70%, 95% confidence interval 0.03%–3.42%).
GLOSSARY
- CHANCE=
- Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events;
- CI=
- confidence interval;
- EQ-5D=
- EuroQol-5 Dimension;
- mRS=
- modified Rankin Scale;
- NIHSS=
- NIH Stroke Scale;
- OR=
- odds ratio
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Coinvestigators are listed on the Neurology® Web site at Neurology.org.
Editorial, page 562
Supplemental data at Neurology.org
- Received November 23, 2014.
- Accepted in final form April 16, 2015.
- © 2015 American Academy of Neurology
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Disputes & Debates: Rapid online correspondence
- Clinical vs statistical significance
- Salvador Cruz-Flores, Professor and Chair, Department of Neurology. Texas Tech University Health Sciences Center El Pasosalvadorcruz7@gmail.com
Submitted September 04, 2015
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