Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

Study Overview
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Brief Summary
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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.

Official Title
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Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Conditions
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Infarction, Middle Cerebral Artery

Intervention / Treatment
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* Procedure: abciximab IV and thrombectomy
* Drug: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs consistent with acute ischemic stroke < 4.5 hours Cerebral infarction and middle cerebral artery occlusion, without any hemorrhage documented by MRI or CT 4 < National Institute of Health Stroke Score (NIHSS) < 25 age > 18 years no prestroke functional dependance : modified Rankin score ≤ 2 subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to french regulations and ethic committee. Exclusion Criteria: pregnant or lactating female coma (vigilance NIHSS > 1) epilepsy recent history of stroke anticoagulant therapy or International Normalized Ratio (INR) > 1.7 ; heparin therapy within past 24 hours and Temps de Cephaline Activee (TCA) extension previous subarachnoid hemorrhage or clinical presentation suggesting a subarachnoid hemorrhage, even if initial CT or MRI scan are normal known hereditary or acquired hemorrhagics diathesis, coagulation factor deficiency uncontrolled hypertension defined as systolic blood pressure ≥ 185 millimeters of mercury (mmHg) or diastolic blood pressure > 110 mmHg at time of admission and time of threat lumbar ar arterial puncture within past 7 days major surgery within past 2 months gastrointestinal hemorrhage or urinary hemorrhage myocardial infarction within past 21 days pericarditis within past 3 months suspicion of bacterial endocarditis within past 3 months previous of aortic dissection baseline lab values : TCA > 40, platelets < 100 000/mm3, glucose < 3 mmol/l or > 22 mmol/l hepatic insufficiency CT or MRI evidence oh hemorrhage CT or MRI evidence of mass effect or intra-cranial tumor CT showing hypodensity or MRI showing hyperdensity involving greater than 1/3 of the middle cerebral artery territory (ASPECT score < 7)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abciximab IV and thrombectomy<br>abciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy | Procedure: abciximab IV and thrombectomy<br> <br> |
| Active Comparator: alteplase<br>alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) | Drug: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recanalization rate |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic intracranial bleeding |  | 24 hours | 
| percentage of patients with a favorable outcome |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Middle Cerebral Artery, Thrombectomy, Mechanical Thrombolysis, Abciximab