Thrombectomy Under Reopro Versus Alteplase to Treat Stoke (TURANDOT)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
SOS Attaque Cérébrale
ClinicalTrials.gov Identifier:
NCT02016547
First received: December 16, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

Resource links provided by NLM:


Further study details as provided by SOS Attaque Cérébrale:

Primary Outcome Measures:
  • recanalization rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomatic intracranial bleeding [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • percentage of patients with a favorable outcome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016547

Locations
France
Stroke Center, Bichat Hospital
Paris, France, 78018
Sponsors and Collaborators
SOS Attaque Cérébrale
  More Information

No publications provided

Responsible Party: SOS Attaque Cérébrale
ClinicalTrials.gov Identifier: NCT02016547     History of Changes
Other Study ID Numbers: 2012-005493-66
Study First Received: December 16, 2013
Last Updated: April 24, 2014
Health Authority: France: Ministry of Health
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by SOS Attaque Cérébrale:
Stroke
Middle Cerebral Artery
Thrombectomy
Mechanical Thrombolysis
Abciximab

Additional relevant MeSH terms:
Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Abciximab
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Anticoagulants
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014