[Integrilin: EARLY ACS trial design and rationale in the June 2005 issue of the American Heart Journal]
>>CAMBRIDGE, Mass., June 28 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced publication of the EARLY ACS trial design and rationale in the June 2005 issue of the American Heart Journal. The EARLY ACS trial design incorporates new technologies and reflects current treatment patterns in patients with non-ST elevation acute coronary syndromes (nSTE ACS) in a "real-world" setting. nSTE ACS is the term applied to unstable angina and non-ST elevation myocardial infarction (MI). The trial is designed to provide important evidence regarding the potential benefit of initiating INTEGRILIN, a potent glycoprotein (GP) IIb-IIIa inhibitor, early after patients present with high-risk acute coronary syndromes (ACS) versus delaying use until patients undergo coronary angiography. In addition, the trial will also explore the ability of biomarkers to identify high-risk patients who will receive the greatest benefit from an early aggressive approach.
"The use of proven therapies, such as GP IIb-IIIa inhibitors has been associated with improved clinical outcomes in patients with nSTE ACS," said Robert P. Giugliano, MD, SM, executive committee member on the EARLY ACS trial, Associate Physician, Cardiovascular Division, Brigham & Women's Hospital and Assistant Professor in Medicine, Harvard Medical School. "The goal of this trial is to investigate the impact of initiating INTEGRILIN early in patients presenting with ACS."
The EARLY ACS trial is a 10,500 patient randomized, double-blind, placebo- controlled, international study evaluating the efficacy and safety of early INTEGRILIN use compared to placebo in reducing death and ischemic complications among patients with high-risk non-ST-elevation (nSTE) ACS in whom an early invasive approach is planned no sooner than the next calendar day. INTEGRILIN will be initiated with the double-bolus dose currently utilized in the cardiac catheterization lab in order for investigators to further evaluate the benefits of early aggressive dosing in achieving superior outcomes for patients with nSTE ACS. The study will also provide physicians with important information to guide treatment decisions based on the interaction between biomarkers, genetics, prognosis, and the magnitude of benefit from early use of INTEGRILIN. The primary endpoint is a composite of all-cause mortality, nonfatal myocardial infarction, recurrent ischemia requiring urgent revascularization, or need for thrombotic bailout with GP IIb-IIIa inhibitor during percutaneous coronary intervention (PCI) within 96 hours of randomization into the study. The key secondary endpoint is the composite of death or nonfatal myocardial infarction within 30 days of enrollment.
"This real-world trial is designed to evaluate definitively the clinical benefits of achieving rapid inhibition of platelet activation through earlier, aggressive use of INTEGRILIN therapy. We expect that the trial will add contemporary data, reflecting current treatment patterns and technologies, to the critical mass of trials that already exist to demonstrate the significant benefits that GP IIb-IIIa inhibitors provide in preventing death and MI in nSTE ACS patients," said Arthur Hiller, senior vice president, sales and marketing at Millennium.<<
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Cheers, Tuck |
