ATLANTA -- Duke University Medical Center cardiologists report that an experimental anti-coagulant that prevents the formation of blood clots earlier in the coagulation process than other agents has cleared another hurdle in becoming a potential new treatment for patients with coronary artery disease.
The new agent, code-named DX-9065a, inhibits the action of Factor Xa (as in Roman numeral X), a pivotal clotting factor of the dozen known factors involved in the complex cascade of biochemical events that ultimately leads to the formation of a blood clot. Duke cardiologist John Alexander, M.D., presented the results of the recently completed Phase II clinical trial today (March 20) at the 51st annual scientific sessions of the American College of Cardiology.
As cardiologists, what we need is an anti-coagulant that achieves predictable concentrations, is easy to dose for individual patients, and works at least as well,
and hopefully better than, current anti-coagulants, Alexander
said. The results of an earlier Phase I trial, and the current
Phase II trial, suggest that this new agent has potential.
Anti-coagulation therapy is widely used to keep clots forming in patients at risk for heart attacks or for those undergoing angioplasty procedures; however, their biggest drawback has been the potential for bleeding complications. Many of these agents have narrow windows for therapeutic effect too little can lead to clot formation, too much can cause bleeding.
The most widely used agent is called unfractionated heparin (UFH). According to Alexander, while it is an effective anti-coagulant, UFH is difficult to use since patient responses to the drug vary widely. During administration, it also requires careful monitoring to ensure therapeutic levels in the blood.
The new trial built upon the results of a Phase I trial known as XaNADU (Xa Neutralization for Atherosclerotic Disease Understanding), which demonstrated the safety
Contact: Richard Merritt