SITS-MOST
Safe Implementation of Thrombolysis in Stroke Monitoring Study
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Status:
Completed. Results were presented in May 2006 at the 15th European Stroke Conference (ESC).
Purpose:
To compare the safety and efficacy of tissue plasminogen activator (TPA) administered in controlled clinical trials to that of TPA prescribed in routine clinical practice.
Location(s):
Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK
Year Started:
2001
Year Finished:
2005
Year Presented:
2006
Design:
Non-controlled, observational study comparing outcomes of non-study patients to those participating in a controlled clinical trial.
Inclusion Criteria
Patients who receive TPA within 3 hours of stroke will be eligible for this study.
Patient Involvement:
Patients are treated according to their clinician's discretion. Physicians who wish to add eligible patients to the registry will supply information regarding the times of onset of stroke, CT scan, and TPA thrombolysis, the patient's gender, prestroke MRS score, the presence of any risk factors (e.g. hypertension, diabetes mellitus, smoking, etc), the patient's stroke subtype, any pretreatment CT, MRI, or transcranial Doppler results, the pretreatment and 24-hour posttreatment NIH Stroke Scale (NIHSS) scores, and stroke etiology. They will also fill out an "outcomes" form reporting CT results at 24-48 hours posttreatment, hemorrhagic complications, mortality, adverse events and 3-month MRS score. These data describing the circumstances of admission and treatment, stroke etiology, and outcome will be compared to results gathered in the treatment arms of controlled clinical trials of TPA.
Primary Outcome:
Death, symptomatic intracranial hemorrhage (SICH), parenchymatous hemorrhage (PH2), disability (defined by a modified Rankin score (MRS) > 2).
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.
Source of Information:
SITS-MOST web site. Presented at 13th European Stroke Conference (May 2004).
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Web Links and Publications:
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This information last updated on: 9/9/2009
Reviewed on: 09/09/2009.
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