Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

NCT ID: NCT02016547

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Infarction, Middle Cerebral Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

abciximab IV and thrombectomy

abciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy

Group Type: EXPERIMENTAL

abciximab IV and thrombectomy

Intervention Type: PROCEDURE

alteplase

alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

Group Type: ACTIVE_COMPARATOR

alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

Intervention Type: DRUG

Interventions

abciximab IV and thrombectomy

Intervention Type: PROCEDURE

alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOS Attaque Cérébrale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stroke Center, Bichat Hospital

Paris, , France

Countries

France

Other Identifiers

2012-005493-66

Identifier Type: -

Identifier Source: org_study_id