ECASS III. NEJM 2008; 359: 1317.
Background: to study the efficacy and safety of IV alteplase when given between 3 and 4.5 hours after the onset of stroke.
Methods: Prospective, multi-center, randomized, double-blind trial. Exclusions similar to NINDS plus patients > 80y, NIHSS > 25, both previous stroke and diabetes, and on anticoagulation regardless of INR. n = 821.
Primary Outcome: disability at 90d (favorable = Rankin score 0 or 1, unfavorable = Rankin score 2-6)
Favorable outcome with alteplase: 52.4% vs 45.2%, ARR 7.2%, NNT = 13.8, p = 0.04
Adverse Events
Any intracranial hemorrhage: 27.0% vs 17.6%, ARI 9.4%, NNT 10.6, p = 0.001
Symptomatic ICH: 2.4% vs 0.2%, ARI 2.2%, NNT = 45, p = 0.008
Mortality: 7.7% vs 8.4%, p = 0.68
Additional Reading
NINDS. NEJM 1995; 333: 1581.
ATLANTIS. JAMA 1999; 282: 2019.
ECASS II. Lancet 1998; 352: 1245.
Marler JR. Lancet 2004; 363:768.
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