Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Thrombectomy Under Reopro Versus Alteplase to Treat Stoke (TURANDOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02016547
Recruitment Status : Terminated
First Posted : December 20, 2013
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):
SOS Attaque Cérébrale

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. recanalization rate [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Symptomatic intracranial bleeding [ Time Frame: 24 hours ]
  2. percentage of patients with a favorable outcome [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02016547

Layout table for location information
Stroke Center, Bichat Hospital
Paris, France, 78018
Sponsors and Collaborators
SOS Attaque Cérébrale
Layout table for additonal information
Responsible Party: SOS Attaque Cérébrale Identifier: NCT02016547    
Other Study ID Numbers: 2012-005493-66
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by SOS Attaque Cérébrale:
Middle Cerebral Artery
Mechanical Thrombolysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Infarction, Middle Cerebral Artery
Pathologic Processes
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors