NCT02016547

Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: SOS Attaque Cérébrale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.

Conditions

• Infarction, Middle Cerebral Artery

Interventions

Type	Name	Description
PROCEDURE	abciximab IV and thrombectomy
DRUG	alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-12-20
• Last updated: 2014-04-25

Locations

1 site across 1 country: France