News | October 30, 2008

New CHARISMA Outcome Study Results Validate Aspirin Effect

October 31, 2008 - Corgenix Medical Corp. recently said new CHARISMA trial findings published in Circulation confirm 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 Oct. 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 (Sinai Center for Thrombosis Research) 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.”

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 showed aspirin and statin treatment were associated with lower concentrations of 11dhTxB2. 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.

For more information: www.aspirinworks.com, http://circ.ahajournals.org, www.healthcheckusa.com

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init