Background
Intravenous
thrombolysis with alteplase within a time window up to 4.5 h is the
only approved pharmacological treatment for acute ischemic stroke. We
studied whether acute ischemic stroke patients with penumbral tissue
identified on magnetic resonance imaging 4.5–9 h after symptom onset
benefit from intravenous thrombolysis compared to placebo.
Methods
Acute
ischemic stroke patients with salvageable brain tissue identified on a
magnetic resonance imaging were randomly assigned to receive standard
dose alteplase or placebo. The primary end point
(totally wrong endpoint, 100% recovery is the ONLY endpoint. Are you that dense?)
was disability at 90
days assessed by the modified Rankin scale, which has a range of 0–6
(with 0 indicating no symptoms at all and 6 indicating death). Safety
end points included death, symptomatic intracranial hemorrhage, and
other serious adverse events.
Results
The
trial was stopped early for slow recruitment after the enrollment of
119 (61 alteplase, 58 placebo) of 264 patients planned. Median time to
intravenous thrombolysis was 7 h 42 min. The primary endpoint showed no
significant difference in the modified Rankin scale distribution at day
90 (odds ratio alteplase versus placebo, 1.20; 95% CI, 0.63–2.27,
P = 0.58). One symptomatic intracranial hemorrhage occurred in the
alteplase group. Mortality at 90 days did not differ significantly
between the two groups (11.5 and 6.8%, respectively; P = 0.53).
Conclusions
Intravenous
alteplase administered between 4.5 and 9 h after the onset of symptoms
in patients with salvageable tissue did not result in a significant
benefit over placebo. (Supported by Boehringer Ingelheim, Germany;
ISRCTN 71616222).
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