FDAnews
www.fdanews.com/articles/82430-schering-reports-titan-tmi-study-results

SCHERING REPORTS TITAN-TMI STUDY RESULTS

November 14, 2005

Schering-Plough has announced that results from its TITAN-TIMI-34 study indicated that the early initiation of Integrilin in the emergency department prior to percutaneous coronary intervention (PCI) for acute ST-segment-elevation myocardial infarction (STEMI) yielded superior coronary artery blood flow, as assessed by TIMI frame counts, the study's primary endpoint.

TITAN was a Phase IV, randomized, open-label, multicenter trial designed to evaluate the efficacy of early initiation of Integrilin in 343 patients undergoing primary PCI for acute STEMI. The study demonstrated that early initiation of Integrilin in the emergency department prior to primary PCI for STEMI, produced statistically significant faster blood flow through the blocked artery. The time required for blood to go through the artery, as assessed by TIMI Frame Count, sped up significantly from 84.3 frames among those treated later in the catheterization lab to 77.5 frames among those treated early in the emergency department. In addition, the percentage of patients with normal blood flow into the heart muscle itself improved from 14.2 percent among patients treated later in the catheterization laboratory to 24.3 percent among those treated earlier in the emergency department.