GUSTO III Study To Start In Summer

The third trial to be carried out by the Global Utilization Strategy for Thrombolysis of Occluded arteries (GUSTO) investigators, GUSTO III, is due to begin this summer, according to Boehringer Mannheim Pharmaceuticals the developer of one of the agents to be tested in the study.

GUSTO III will compare the two thrombolytics reteplase (recombinant plasminogen activator) and Activase (alteplase; tissue plasminogen activator). Boehringer Mannheim is testing reteplase in Phase III trials. r-PA is a modification of the t-PA molecule which confers a longer half-life in the body, and allows delivery in two single bolus injections.

The study will be tested in 10,000-12,000 patients at around 500 centers across the USA and Europe. It will be coordinated by GUSTO chairman Eric Topol of the Cleveland Clinic Foundation and Robert Califf of Duke University Medical Center. It will provide a quantitative comparison of the accelerated dosing regimen of alteplase (affirmed in the original GUSTO study) and the double bolus regimen of reteplase. Building on comparative data from the RAPID 1 and RAPID 2 studies, GUSTO III is a one-year mortality trial designed to "offer a comparison of the two agents on a variety of levels."