Anti-clotting effects reversed within two minutes
Volunteers at the Jack and Linda Gill Heart Institute at the University of Kentucky were the first ever to receive a new anti-clotting therapy. The drug and its antidote are being developed for their effectiveness in preventing blood clots while at the same time providing physicians the ability to rapidly reverse the effects of the blood thinner to help safeguard patients against uncontrolled bleeding.
More than 12 million patients are prescribed so-called "blood thinners" each year to prevent the formation of clots, which can block blood vessels, causing heart attacks, strokes and other debilitating or life-threatening conditions. Blood thinners, or antithrombotics, pose a risk of bleeding, particularly during surgery. The ability to stop the anti-clotting effects quickly could help protect patients from uncontrolled bleeding.
The Gill Heart Institute is one of two sites participating in the Phase 1 trial and is the first site to use the anti-clotting drug and its antidote.
This clinical trial will examine the drug's safety and tolerability in healthy volunteers as well as the antidote's ability to quickly reverse its effects. Although other new antithrombotics are undergoing testing in the U.S., this drug is believed to be the first of its kind.
"This class of drugs is a very promising technology that allows for the development of 'designer' drugs and their antidotes simultaneously," said Dr. Steven R. Steinhubl, the study's principal investigator at UK and director of cardiovascular education and clinical research at the Gill Heart Institute and a UK College of Medicine associate professor of cardiology. "It could have far-reaching implications."
"The research capacity of the cardiology division at UK has skyrocketed in the last year. Millions of dollars in research projects are under way, and we have attracted world-recognized leaders in drug discovery and development, such as Dr. Steinhubl. Leaders of technology and pharmaceutical companies have visited us in Lexington and are entrusting us to pioneer the next-generation of medicines and devices to improve healthcare," said Dr. David Moliterno, professor and vice chair of medicine, and chief, division of cardiovascular medicine, UK College of Medicine, and co-director of the UK Gill Heart Institute.
"Our goal is simple: we want to help patients with heart and vascular disorders by being at the forefront. Our research efforts are clearly bringing Kentuckians closer to the leading edge of the best medicine has to offer," Moliterno said.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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Don't be too timid and squeamish about your actions. All life is an experiment. The more experiments you make the better.
-- Ralph Waldo Emerson