FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke


Phase 2 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.