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Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke (THRACE)

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ClinicalTrials.gov Identifier: NCT01062698
Recruitment Status : Terminated (Efficacy)
First Posted : February 4, 2010
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

THRACE is a controled, multicenter and randomized trial.

The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale [NIHSS] ≥ 10).

The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.


Condition or disease Intervention/treatment
Cerebral Stroke Cerebrovascular Accident Drug: Alteplase (rt-PA)/Actilyse Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis
Study Start Date : June 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: IV thrombolysis + thrombectomy Drug: Alteplase (rt-PA)/Actilyse
Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.
Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Mechanic thrombectomy
Active Comparator: IV thrombolysis Drug: Alteplase (rt-PA)/Actilyse
Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.


Outcome Measures

Primary Outcome Measures :
  1. Modified Rankin Score (mRs ) [ Time Frame: 3 months after treatment ]

Secondary Outcome Measures :
  1. Quality of Life (Euroqol EQ-5D) [ Time Frame: 3 months after treatment ]
  2. Barthel Score [ Time Frame: 3 months after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10<=NIHSS Score=<25
  • Symptoms onset less than 4 hours
  • Occlusion of the intracranial carotid, the middle cerebral artery (M1) or the upper third of the basilar

Exclusion Criteria:

  • Contraindications for intravenous thrombolysis
  • Occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion
  • Any cause local prohibiting femoral catheterization
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01062698


Locations
France
Central Hospital Nancy (Central HNF)
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Serge Bracard, Pr Central Hospital Nancy France (HNF)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Directeur de la Recherche et de l'Innovation, Professor Serge BRACARD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01062698     History of Changes
Other Study ID Numbers: 2009-A00753-54
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Directeur de la Recherche et de l'Innovation, Central Hospital, Nancy, France:
mechanical Thrombectomy
CVA (Cerebrovascular Accident)
Cerebrovascular Accident, Acute

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action