January 4, 2011International Journal of Stroke
Effect of Clopidogrel plus ASA vs. ASA Early after TIA and Ischaemic Stroke: A Substudy of the CHARISMA Trial
Key result
Adding clopidogrel to acetylsalicylic acid in patients with TIA or ischaemic stroke resulted in a stroke rate of 4.9% vs 6.1% with placebo (HR 0.80; 95% CI 0.62-1.03).
Why the study?
Does clopidogrel added to acetylsalicylic acid reduce stroke in patients with transient ischaemic attack or ischaemic stroke?
Population
4,320 patients with transient ischaemic attack or ischaemic stroke
Comparison
Clopidogrel added to background therapy with… vs Placebo added to background therapy with…
Design
RCT, randomised, double-blind, placebo-controlled
Authors
Discussion
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Implication
Does not support adding clopidogrel to aspirin after TIA or ischaemic stroke; leaves open benefit for confirmation in larger trials.
Study Design
Type
RCT (n=4,320)
Blinding
double-blind
Randomization
randomised
Structured PICO
Does clopidogrel added to acetylsalicylic acid reduce stroke in patients with transient ischaemic attack or ischaemic stroke?
P
Population
4,320 patients with transient ischaemic attack or ischaemic stroke.
I
Intervention
Clopidogrel added to background therapy with low-dose acetylsalicylic acid
C
Comparator
Placebo added to background therapy with low-dose acetylsalicylic acid
O
Outcome
Stroke during the follow-up periodhard clinical
Main Result
Hazard Ratio: 0.8 (95% CI 0.62–1.03)
Absolute Event Rate: 4.9% vs 6.1%
The addition of clopidogrel to aspirin in patients with TIA or ischemic stroke shows a non-significant trend towards reduced stroke without significantly increasing severe bleeding, generating a hypothesis for future dedicated trials.
Limitations
- Subanalysis not adequately powered to prove the hypothesis
- Not adequately powered to prove the hypothesis
Cite This Study
Hankey et al. (2011) conducted an RCT in Transient ischaemic attack and ischaemic stroke (n=4,320). Clopidogrel vs. Placebo was evaluated on stroke (HR 0.80, 95% CI 0.62-1.03). Adding clopidogrel to acetylsalicylic acid in patients with TIA or ischaemic stroke resulted in a stroke rate of 4.9% vs 6.1% with placebo (HR 0.80; 95% CI 0.62-1.03).