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CHARISMA The stroke substudy

Rationale In secondary prevention trials, the composite endpoint usually includes stroke (mostly both, ischemic and hemorrhagic).Several trials have used TIA and stroke as endpoints.With this approach it makes no difference whether the stroke was fully reversible, mild, devastating, or even dead

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CHARISMA The stroke substudy

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    1. CHARISMA The stroke substudy Werner Hacke MD PhD for the CHARISMA Executive Committee and Investigators

    2. Rationale In secondary prevention trials, the composite endpoint usually includes stroke (mostly both, ischemic and hemorrhagic). Several trials have used TIA and stroke as endpoints. With this approach it makes no difference whether the stroke was fully reversible, mild, devastating, or even deadly. It could be of interest to evaluate, whether the treatment tested not only prevents stroke, but also changes stroke severity. Only rarely, in exploratory analyses, some measure of vaguely defined stroke outcome has been included: eg, disabling stroke (NASCET) CHARISMA ? The stroke substudy

    3. In CHARISMA, we prospectively designed a substudy looking at the severity of stroke events occurring during the observation period. Design Compares the effect of clopidogrel vs placebo on top of standard therapy including low-dose ASA on functional outcome at 90 days in patients experiencing a stroke endpoint in CHARISMA. It is hypothesized that there may be an effect of double antiplatelet therapy (AP) on stroke severity and outcome as measured by the modified Rankin Scale (mRS) three months after the event. CHARISMA ? The stroke substudy

    4. Method All patients with an adjudicated stroke event were assessed after three months using the mRS Primary endpoint: mRS distribution Cochran-Mantel-Haenszel Sample size Since CHARISMA was an event-driven trial, no formal sample size calculation was possible It was hypothesized that of the >15 000 patients about 300 patients would suffer a stroke CHARISMA ? The stroke substudy

    5. Results Stroke was the most frequent event of the composite primary endpoint in the trial Clopidogrel Placebo More patients than assumed reached a stroke endpoint Unadjudicated 503 (235 clopidogrel; 268 placebo) Adjudicated and follow-up 441 (205 clopidogrel; 236 placebo) Time to first stroke (days) 232 d clopidogrel; 207d placebo

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