Nervous System Disorders Clinical Trial
Official title:
Randomized Therapeutic Study Assessing the Superiority of a Sequential Intravenous Thrombolysis Treatment (Rt-PA + Tenecteplase) in Comparison With Rt-PA Standard Treatment in Proximal Middle Cerebral Artery Occlusion (DIVA).
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.
This is a Phase 2, multi-center, national, randomized, biomedical study comparing two
therapeutic strategies in ischemic stroke associated with proximal middle cerebral artery
occlusion.
Patients will be included in two randomized arms and the new sequential treatment approach
(rt-PA + tenecteplase) will be compared with the standard treatment (rt-PA alone).
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