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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):
Directeur de la Recherche et de l'Innovation, Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE February 3, 2010
First Posted Date  ICMJE February 4, 2010
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE June 2010
Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2010)
Modified Rankin Score (mRs ) [ Time Frame: 3 months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2010)
  • Quality of Life (Euroqol EQ-5D) [ Time Frame: 3 months after treatment ]
  • Barthel Score [ Time Frame: 3 months after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke
Official Title  ICMJE The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Stroke
  • Cerebrovascular Accident
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: IV thrombolysis + thrombectomy
    Interventions:
    • Drug: Alteplase (rt-PA)/Actilyse
    • Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
  • Active Comparator: IV thrombolysis
    Intervention: Drug: Alteplase (rt-PA)/Actilyse
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
412
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2010)
480
Study Completion Date  ICMJE March 2016
Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01062698
Other Study ID Numbers  ICMJE 2009-A00753-54
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Directeur de la Recherche et de l'Innovation, Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serge Bracard, Pr Central Hospital Nancy France (HNF)
PRS Account Central Hospital, Nancy, France
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP