NINDS
Trial question
What is the role of tPA in patients with ischemic stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 624
624 patients (260 female, 364 male).
Inclusion criteria: patients with ischemic stroke.
Key exclusion criteria: receipt of anticoagulants or heparin within the 48 hours preceding the onset of stroke, PTs > 15 seconds, platelet counts < 100,000/mm², or glucose concentrations < 50 mg/dL or > 400 mg/dL.
Interventions
N=312 tPA (alteplase at a dose of 0.9 mg/kg of body weight, maximum 90 mg).
N=312 placebo (matching placebo).
Primary outcome
Death at 90 days
17%
21%
21.0 %
15.8 %
10.5 %
5.3 %
0.0 %
Tissue plasminogen
activator
Placebo
No significant
difference ↔
No significant difference in death at 90 days (17% vs. 21%; RR 0.81, 95% CI -0.71 to 2.33).
Safety outcomes
Significant differences in symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke (6.4% vs. 0.6%, p < 0.001).
Conclusion
In patients with ischemic stroke, tPA was superior to placebo with respect to death at 90 days.
Reference
National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7.
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