Thrombectomy Under Reopro Versus Alteplase to Treat Stoke (TURANDOT)

Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

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.

Study Overview

• Status: Terminated
• Conditions: Infarction, Middle Cerebral Artery
• Intervention / Treatment: Procedure: abciximab IV and thrombectomy; Drug: alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 78018
    • Stroke Center, Bichat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recanalization rate	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SOS Attaque Cérébrale

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): February 1, 2015
• Study Completion (ANTICIPATED): February 1, 2015

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (ESTIMATE): December 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Abciximab; Middle Cerebral Artery; Mechanical Thrombolysis
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Infarction; Infarction; Infarction, Middle Cerebral Artery; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Anticoagulants; Tissue Plasminogen Activator; Abciximab
• Other Study ID Numbers: 2012-005493-66