CINCINNATI—A new clinical trial at the University of Cincinnati and UC Health University Hospital may help doctors determine the best way to prevent blood clotting in patients with coronary artery disease who receive drug-coated stents.
The multi-center study—known as the CYPRESS Trial—will look at the clinical outcomes of 2,500 patients nationally who take anti-platelet therapy (blood thinners) following coronary stenting.
Massoud Leesar, MD, UC Health cardiologist and lead investigator of the study at UC, says patients are given two anti-platelet agents following stenting procedures: aspirin and Plavix (clopidogrel bisulfate), a blood thinner.
"The Food and Drug Administration recommends that patients receive these agents for a year following their stent placement to avoid blood clots from forming and causing other serious health issues, like stroke or pulmonary embolism,” he says. "No studies have been done to show if these medications are beneficial beyond that. This study will help determine if administering blood thinners to patients for a longer period of time will result in added health benefits.”
Patients involved in the study will receive the standard treatment for 12 months. When the 12 months are up, some patients will receive aspirin and a blood thinner daily while others will receive aspirin and a placebo. Their progress will be documented for an additional 18 months.
Leesar says this study will help physicians determine if the use of blood thinners is beneficial for all patients or just certain subgroups.
"Blood thinners have side-effects and are expensive,” he says. "Obviously, we don’t want patients taking the agents if they aren’t helpful. We want to see if they are beneficial beyond 12 months for patients across the board or only for those who are at a higher risk of clotting, such as those with diabetes, hypertension, or heart failure.
"This study has the potential to set the standard for future care of patients after stenting and to create better outcomes in treatment.”
This study is being conducted by Cordis Corporation, a Johnson & Johnson Company. This study is part of a larger clinical trial sponsored by Harvard Clinical Research Institute, including 20,645 subjects mandated by the FDA. Leesar cites no conflict of interest and does not receive honoraria from the manufacturers of Plavix.