Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion
Status:
Withdrawn
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke.
Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective
treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to
50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by
rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no
recanalization after rt-PA. A case series of 13 consecutive patients treated by this
association has been published in 2011. A high rate of recanalization without hemorrhagic
transformation increase has been reported. However, efficiency and safety of this therapeutic
have to be assessed in a randomized multi-centric study. Such a study is of great interest
since interventional neuroradiology has not already shown superiority regarding IV rt-PA.
Moreover interventional neuroradiologists specialists are only available in major hospital
and an IV sequential strategy could provide an interesting alternative.
Main study objectives:
Main Clinical Objective:
Sequential thrombolysis should be associated with a significant better outcome at 3-month,
assessed by the modified Rankin score (mRS).
Main Radiological Objective:
Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3)
at 24-hour.