Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS)

• DOI: 10.1161/01.str.0000217403.66996.6d
• Publication Date: 2006-03-31T01:59:11Z
• Authors: Anthony J. Furlan; Dirk Eyding; Gregory W. Albers; Yasir Al-Rawi; Kennedy R. Lees; Howard A. Rowley; Christian Sachara; Mariola Soehngen; Steven Warach; Werner Hacke
• Keywords: Stroke; Clinical endpoint

Desmoteplase is a novel plasminogen activator with favorable features in vitro compared available agents. This study evaluated safety and efficacy of intravenous (IV) desmoteplase patients perfusion/diffusion mismatch on MRI 3 to 9 hours after onset acute ischemic stroke.DEDAS was placebo-controlled, double-blind, randomized, dose-escalation investigating doses 90 microg/kg 125 desmoteplase. Eligibility criteria included baseline National Institute Health Stroke Scale (NIHSS) scores 4 20 evidence mismatch. The end point the rate symptomatic intracranial hemorrhage. Primary co-end points were reperfusion 8 treatment good clinical outcome at days. primary analyses intent-to-treat. Before unblinding, target population, excluding violating specific criteria, defined.Thirty-seven randomized received (intent-to-treat; placebo: n=8; microg/kg: n=14; n=15). No hemorrhage occurred. Reperfusion achieved 37.5% (95% CI [8.5; 75.5]) placebo patients, 18.2% (2.3; 51.8) treated desmoteplase, 53.3% (26.6; 78.7) Good days occurred 25.0% (3.2; 65.1) placebo, 28.6% (8.4; 58.1) 60.0% (32.3; 83.7) In population (n=25), difference increased statistically significant for (P=0.022).Treatment IV stroke appears safe. At dose appeared improve outcome, especially fulfilling all criteria. results DEDAS generally support its predecessor study, Acute Ischemic (DIAS).