First Phase II Data With Argatroban In AMI

Texas Biotechnology has presented the preliminary results from the first of its three multicenter studies of Novastan (argatroban), a direct thrombin inhibitor, as an adjunctive treatment to thrombolytic therapy in patients suffering an acute myocardial infarction. The data were presented at the 14th International Congress on Thrombosis in Montpellier, France on October 21.

Pierre Theroux of the Montreal Heart Institute in Canada, the lead investigator in the study, presented angiographic data from the trial, called ARG-230(a). Clinical endpoint data will be generated in a companion study, ARG 230, which is still ongoing.

ARG-230(a) was conducted at 15 sites in North and South America and was designed to test the ability of Novastan to speed the opening of blocked coronary arteries at 90 minutes after the initiation of therapy. A total of 180 patients were randomized to receive either 1mcg/kg argatroban, 3mcg/kg argatroban or placebo plus 1.5 million units of streptokinase within six hours of the onset of symptoms of acute MI. Effectiveness was measured by assessing the speed of coronary artery reperfusion using an angiographic technique known as TIMI frame counting.