ECASS III
Trial question
What is the effect of intravenous alteplase administered after 3 to 4.5 hours in patients with AIS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 821
821 patients (326 female, 495 male).
Inclusion criteria: patients with ischemic stroke.
Key exclusion criteria: ICH or major ischemic infarction as detected on CT scan, seizure at the onset of stroke, stroke or serious head trauma within the previous 3 months, OAC treatment, or increased risk of bleeding.
Interventions
N=418 alteplase (intravenous dose of 0.9 mg/kg of body weight).
N=403 placebo (identical placebo IV).
Primary outcome
Modified Rankin Scale score < 2
52.4%
45.2%
52.4 %
39.3 %
26.2 %
13.1 %
0.0 %
Alteplase
Placebo
Significant
increase ▲
NNT = 13
Significant increase in mRS score < 2 (52.4% vs. 45.2%; OR 1.34, 95% CI 1.02 to 1.76).
Safety outcomes
No significant differences in mortality (7.7% vs. 8.4%, p = 0.68) and other serious adverse events.
Significant differences in any ICH (27.0% vs. 17.6%, p = 0.001) and symptomatic ICH (2.4% vs. 0.2%, p = 0.008).
Conclusion
In patients with ischemic stroke, alteplase was superior to placebo with respect to mRS score < 2.
Reference
Hacke W, Kaste M, Bluhmki E et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29.
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