CHARISMA Study Results Validate Aspirin Effect
Corgenix Medical Corporation (OTC Bulletin Board: CONX) announces that new CHARISMA trial findings published in Circulation confirm that elevated urinary levels of the biomarker 11-dehydro thromboxane B2 (11dhTxB2) indicate an increased risk of heart attack, stroke and cardiac death.
The AspirinWorks Test by Corgenix is the only FDA-cleared test that measures urinary 11dhTxB2 to accurately determine aspirin effect in apparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane, the target of aspirin therapy.
The new findings, published in the October 21 issue of the American Heart Association's peer-reviewed medical journal Circulation, directly link increased levels of this powerful biomarker to a patient's risk of heart attack and stroke, potentially changing how millions of people worldwide are tested for aspirin effect and treated to prevent heart attacks and strokes.
The sub-study of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial was carried out with the pre-FDA-cleared version of the AspirinWorks Test. The test subsequently received FDA clearance in May 2007 and is available worldwide.
Cardiologist Paul A. Gurbel, M.D., Director, Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore, said the study supports that measurement of urinary 11-dehydro thromboxane B2 can identify patients at risk for ischemic events and can be used as an independent risk factor for heart disease and stroke.
"Interestingly, the investigators observed a dose-dependent effect of aspirin on levels of this marker," explained Gurbel. "These data are consistent with our previous randomized data from the double crossover ASPECT study that evaluated the effect of three 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 the AspirinWorks test a strong and unique position in the U.S. and global cardiovascular diagnostic testing market place."