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New CHARISMA Outcome Study Results Validate Aspirin Effect
Date:10/21/2008

e commonly used aspirin doses published last year in Circulation. We also found a reduction in 11-dehydro thromboxane B2 between 81 mg and 325 mg.

"These findings strongly support the role of urinary 11-dehydro thromboxane B2 concentrations as an independent predictor of cardiovascular risk in aspirin-treated patients," said Gurbel. "The findings of both the ASPECT study and current investigation also raise the potential for adjusting aspirin doses to modify risk by reducing in vivo thromboxane synthesis."

CHARISMA is a multinational, multicenter, randomized, parallel group, double-blind trial involving 15,603 patients with either clinically established cardiovascular disease or multiple risk factors. The pre-specified CHARISMA sub-study involved a total of 3,261 aspirin-treated patients from 224 sites in 12 countries.

Among the principal findings was that the upper quartile of urinary 11dhTxB2 concentration in a broad population of high-risk patients treated with usual doses of aspirin (75 to 325 mg) was independently associated with an increased risk of serious cardiovascular events. Other findings from the trial include:

1) Aspirin and statin treatment were associated with lower concentrations of 11dhTxB2.

2) Randomization to clopidogrel (vs. placebo) did not reduce urinary 11-dehydro thromboxane B2 levels nor did it reduce the hazard of cardiovascular events in patients in the highest quartile of urinary 11dhTxB2 levels.

"This is the outcome study we have all been waiting for because it demonstrates the potential value of the AspirinWorks test (11dhTxB2) for optimizing an individual's aspirin therapy. The publication of these findings in one of the most prestigious medical journals further demonstrates the value and viability of the AspirinWorks product," said Douglass Simpson, Corgenix' President and Chief Executive Officer. "The ability to quickly, easily and accurately determine the effect of aspirin in patients gives
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SOURCE Corgenix Medical Corporation
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