FRALYSE
FRALYSE Trial: Comparison of the Classical rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
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Status:
This study has been suspended.
Purpose:
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.
Year Started:
2001
Year Finished:
2008
Year Presented:
2010
Design:
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Interventional.
Inclusion Criteria
Symptoms of ischemic stroke; presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS); lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry; time of therapy less than 7 hours after onset of stroke; permanent or aggravating symptoms.
Exclusion Criteria
Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy; no surgery within 14 days before therapy; history of cerebral bleeding; blood pressure: systolic >185 mmHg and/or diastolic >110 mmHg; minor symptoms or symptoms rapidly improving; gastro-intestinal or urinary hemorrhage within 21 days; arterial puncture within 7 days before therapy; epileptic seizure at the beginning of stroke; patients under oral anticoagulants or having received heparin within 48 hours, and with elevated activated partial thromboplastin time (aPTT); patients with elevated International Normalized Ratio (INR) or thrombocyte count < 100 x 10^9; blood glucose value < 2.7 mmol/l or > 22.2 mmol/l; cardiac, pulmonary, hepatic or renal failure, not allowing a study over 3 months; history of gastric ulcer within 15 days; gestation and menstruation.
Patient Involvement:
Patient to receive alteplase 0.9mg/kg over 60 minutes in arm with a "classical dose" and alteplase 0.8mg/kg over 90 minutes in arm with a "low dose-longer infusion".
Primary Outcome:
Modified Rankin score at day 90.
Results:
From 2001 to 2008, 373 patients have been included in FRALYSE-clinical and 65 in FRALYSE-MRI (median OTT: 230 min., median baseline NIHSS : 14). The proportion of patients after 3 hours was 80%. The overall security included a mortality of 8.4% and a symptomatic hemorrhagic rate of 4.3% as per SITS-MOST. The global excellent outcome rate (mRS 0,1) was 35.7 % (intention to treat and 36.2% in per protocol analysis. A late efficacy rebound of 39.4% mRS 0,1 was observed in patients treated between 4.5 and 7 hours. In the FRALYSE clinical analysis, there was no
statistical difference between the proportion of mRS 0-1 patients in the NINDS (36.1%) and LTP (35.2%) groups, although there was a trend to a slight superiority of LTP in patients 30 and 3Hours. Conversely, FRALYSE MRI showed a significant superiority of LTP in terms of mismatch volume decrease (p0.04). Conclusions 1. “Mass thrombolysis” including systematically patients within 7 hours is safe and yields an honorable output of 36.2%. 2. This enlargement of the window multiplies by 5 the eligibility and increases considerably the benefit to humanity performed by a neurovascular unit. If one compares the 3-7 cohort to the NINDS placebo group, 38.1 lifes were saved and 47.5 brains salvaged (mRS 0,1) by the opening of the window from 3 to 7 hours. 3. The LTP procedure, which was designed before the NINDS, is clinically equivalent to NINDS, despite its superiority on MRI.
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Source of Information:
NIH Clinical Trial site.
Presented at the 2010 International Stroke Conference (February 2010).
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Web Links and Publications:
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This information last updated on: 5/25/2010
Reviewed on: 05/25/2010.
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