Safe Implementation of Thrombolysis in Stroke Monitoring Study "SITS-MOST"


Phase N/A Results


Overall, the results confirmed that routine clinical use of rtPA within 3 hours of stroke onset is as safe as previously reported. Patients' data was compared to prior randomized clinical trials, and small but significant differences were seen for previous stroke (9.9% vs 16.0%: P <.0001); and aspirin use (30.4% vs 28.0%; P =.03), also for hypertension (57.8% vs 54.6%; P =.008); diabetes (15.8% vs 19.2%; P =.001); atrial fibrillation (23.6% vs 19.7%; P =.0001); and coronary heart failure (7.8% vs 15.8%; P <.0001). Hemorrhage was seen in 15.7% of the patients at 22 to 36-hour imaging follow-up, with 1.5% of them symptomatic with an NIHSS score of >/= 4-point deterioration plus PH2 bleeding. The mortality rate was 12.8%, showing borderline significance according to the lower 95% CI for mortality from prior trials, and the independence at 3 months (mRS 0-2) was 53.4%, which lies within the upper 95% CI for independence from prior trials. This trial showed a 3.4% improvement in direct comparison across the full mRS at 3 months with other randomized clinical trials, which showed a 10% improvement for rtPA use over placebo.