Thrace is a French randomized, multicenter, controlled trial on mechanical thrombectomy for large cerebral arteries acute occlusions.
Primary objective was to determine whether a combined IVT/IAMT is superior to standard IV rTpa alone when initiated within 4h of acute ischemic stroke onset in adult patients with moderate-to-severe strokes (NIHSS>10) due to large artery occlusion. The primary outcome measure was the good clinical outcome (mRs 0-2) at 3 months.
Complete data were analyzed for the 2nd intermediate analysis using O’Brien and Fleming stopping rules.
Results: 412 patients were included. For the second intermediate analysis, 395 patients were considered. Data were complete and monitored for 385 patients (195 IV/ 190 IV+IAMT).
The mean age of our population was 62.5 years and the median NIHSS= 18. Occlusions were located on C1 in 57 (14,8%) and M1 in 326 cases (84,6%) At 3 months, the difference of good outcome between the two arms was significant according to the O’Brien-Fleming boundaries.
Conclusion: After this intermediate analysis, THRACE was considered as positive and the Scientific Committee, following the DSMB advice, decided to stop the study. The final results will be presented.