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Thrombectomy Under Reopro Versus Alteplase to Treat Stoke (TURANDOT)

Primary Purpose

Infarction, Middle Cerebral Artery

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

abciximab IV and thrombectomy

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

About this trial

This is an interventional treatment trial for Infarction, Middle Cerebral Artery focused on measuring Stroke, Middle Cerebral Artery, Thrombectomy, Mechanical Thrombolysis, Abciximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Stroke Center, Bichat Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

abciximab IV and thrombectomy

alteplase

Arm Description

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

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

Outcomes

Primary Outcome Measures

recanalization rate

Secondary Outcome Measures

Symptomatic intracranial bleeding

percentage of patients with a favorable outcome

Full Information

NCT ID

NCT02016547

First Posted

December 16, 2013

Last Updated

April 24, 2014

Sponsor

SOS Attaque Cérébrale

1. Study Identification

Unique Protocol Identification Number

NCT02016547

Brief Title

Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

Acronym

TURANDOT

Official Title

Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Study Start Date

September 2013 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOS Attaque Cérébrale

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infarction, Middle Cerebral Artery

Keywords

Stroke, Middle Cerebral Artery, Thrombectomy, Mechanical Thrombolysis, Abciximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

abciximab IV and thrombectomy

Arm Type

Experimental

Arm Description

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

Arm Title

alteplase

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

abciximab IV and thrombectomy

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

recanalization rate

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Symptomatic intracranial bleeding

Time Frame

24 hours

Title

percentage of patients with a favorable outcome

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Stroke Center, Bichat Hospital

City

Paris

ZIP/Postal Code

78018

Country

France

12. IPD Sharing Statement

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Thrombectomy Under Reopro Versus Alteplase to Treat Stoke

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