DIAS-- desmoteplase in acute ischemic stroke -- placebo controlled, double blind, dose-finding randomized Phase II trial designed to evaluate safety and efficacy of desmoteplase. Looked at patients presenting 3-9 hours, enrolled 2001-2003 104 patients with NIHSS of 4-20 and mismatch on perfusion/diffusion imaging. Doses were 25, 37.5, and 50 mg of drug given as an iv bolus over two minutes. Due to excess symptomatic ICH lower doses were investigated in part 2 (62.5, 90 and 125 ug/kg). Safety outcome was rate of sICH, efficacy outcome measures were rate of reperfusion after 4-8 hours and NIHSS, mRS and Barthel at 90 days. In part excess s ICH was seen (23-30 % all within 24 hours). In part 2, the rate of sICH was 2.2%. In part 2 rates of reperfusion UP TO 71.4 % were seen at 125 ug dose compared to 19.2 % with placebo. Good clinical outcome was seen in 22 % of placebo treated patients and 13.3-60 % of drug treated patients (proportional to higher dose) also corresponding with early reperfusion. Overall 52 % of patients with reperfusion had favorable outcome v 24.6 % without.
Conclusions-- DIAS showed iv lysis is safe at 3-9 hours in patients with mismatch on MRI and dose dependent reperfusion correlated with clinical outcome. Outcome at 6-9 hours was as good as 3-6 hours. A phase 3 trial comparing 90 and 125 ug / kg doses in ongoing.
Subscribe to:
Post Comments (Atom)
1 comment:
DEDAS (dose escalation study of desmoteplase in acute ischemic stroke) was companion trial of 37 patients, ph 2, same criteria Furlan lead investigator. there were no sICH. The placebo group had n=8, 90 ug/kg n=14, 125 ug/kg n= 15. Reperfusion occurred in 37.5 % placebo, 51 % low dose, 53 % high dose. Good clinical outcome at 90 days occurred in 25 % placebo, 28 % low dose, and 60 % of high dose.(p=0.022).
Post a Comment