Millennium, partner begin trial with INTEGRILIN (eptifibatide) Injection.

2004 JUL 1 - (NewsRx.com & NewsRx.net) -- Millennium Pharmaceuticals, Inc., (MLNM) and Schering-Plough Corp. (SGP) announced the initiation of a multicenter, phase IIIb, clinical trial to evaluate the benefit of INTEGRILIN when administered early to high-risk patients experiencing non-ST-segment elevation acute coronary syndrome.

The trial, known as EARLY ACS (early glycoprotein IIb-IIIa inhibition in non-st-segment elevation acute coronary syndrome: a randomized, placebo-controlled trial evaluating the clinical benefits of early front-loaded eptifibatide in the treatment of patients with non-st-segment elevation acute coronary syndrome) will evaluate the benefit of INTEGRILIN compared to placebo in reducing death and other major adverse cardiac events, including heart attack, within 96 hours and up to 30 days following randomization.

EARLY ACS is designed to include 10,500 patients at 500 sites worldwide.

"This trial is a high priority for Millennium because evidence suggests that early intervention with a glycoprotein (GP) IIb-IIIa inhibitor such as INTEGRILIN - as currently recommended by the ACC/AHA [American College of Cardiology/American Hospital Association] Guidelines - can significantly reduce the high incidence of heart attack and in-hospital mortality," said Nancy Simonian, MD, senior vice president, clinical development at Millennium.

"We believe that this trial will provide further clinical evidence to support findings from the CRUSADE quality improvement initiative which to date suggest that adherence to the guidelines in the early stages of an adverse cardiac event can help save patients' lives," she added.

The EARLY ACS trial will evaluate the effectiveness of INTEGRILIN (eptifibatide) Injection in an early use setting, when emergency room patients are diagnosed as being at high-risk for a heart attack or death and are ...