TURANDOT: Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

Sponsor

SOS Attaque Cérébrale (Other)

Overall Status

Terminated

CT.gov ID

NCT02016547

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infarction, Middle Cerebral Artery	Procedure: abciximab IV and thrombectomy Drug: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2015

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: abciximab IV and thrombectomy 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
Active Comparator: alteplase 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)

Arm

Intervention/Treatment

Experimental: abciximab IV and thrombectomy

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

Active Comparator: alteplase

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)

Outcome Measures

Primary Outcome Measures

recanalization rate [24 hours]

Secondary Outcome Measures

Symptomatic intracranial bleeding [24 hours]
percentage of patients with a favorable outcome [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)