Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke (THRACE)
Primary Purpose
Cerebral Stroke, Cerebrovascular Accident
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alteplase (rt-PA)/Actilyse
Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke focused on measuring mechanical Thrombectomy, CVA (Cerebrovascular Accident), Cerebrovascular Accident, Acute
Eligibility 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
Sites / Locations
- Central Hospital Nancy (Central HNF)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IV thrombolysis + thrombectomy
IV thrombolysis
Arm Description
Outcomes
Primary Outcome Measures
Modified Rankin Score (mRs )
Secondary Outcome Measures
Quality of Life (Euroqol EQ-5D)
Barthel Score
Full Information
NCT ID
NCT01062698
First Posted
February 3, 2010
Last Updated
July 20, 2017
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT01062698
Brief Title
Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke
Acronym
THRACE
Official Title
The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Efficacy
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2015 (undefined)
Study Completion Date
March 2016 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Cerebrovascular Accident
Keywords
mechanical Thrombectomy, CVA (Cerebrovascular Accident), Cerebrovascular Accident, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV thrombolysis + thrombectomy
Arm Type
Active Comparator
Arm Title
IV thrombolysis
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Alteplase (rt-PA)/Actilyse
Intervention Description
Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.
Intervention Type
Procedure
Intervention Name(s)
Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Intervention Description
Mechanic thrombectomy
Primary Outcome Measure Information:
Title
Modified Rankin Score (mRs )
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Quality of Life (Euroqol EQ-5D)
Time Frame
3 months after treatment
Title
Barthel Score
Time Frame
3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Bracard, Pr
Organizational Affiliation
Central Hospital Nancy France (HNF)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital Nancy (Central HNF)
City
Nancy
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35698971
Citation
Janvier P, Kerleroux B, Turc G, Pasi M, Farhat W, Bricout N, Benzakoun J, Legrand L, Clarencon F, Bracard S, Oppenheim C, Boulouis G, Henon H, Naggara O, Ben Hassen W. TAGE Score for Symptomatic Intracranial Hemorrhage Prediction After Successful Endovascular Treatment in Acute Ischemic Stroke. Stroke. 2022 Sep;53(9):2809-2817. doi: 10.1161/STROKEAHA.121.038088. Epub 2022 Jun 14.
Results Reference
derived
PubMed Identifier
34103393
Citation
Riou-Comte N, Gory B, Soudant M, Zhu F, Xie Y, Humbertjean L, Mione G, Oppenheim C, Guillemin F, Bracard S, Richard S; THRACE investigators. Clinical imaging factors of excellent outcome after thrombolysis in large-vessel stroke: a THRACE subgroup analysis. Stroke Vasc Neurol. 2021 Dec;6(4):631-639. doi: 10.1136/svn-2020-000852. Epub 2021 Jun 8.
Results Reference
derived
PubMed Identifier
33184069
Citation
Derraz I, Pou M, Labreuche J, Legrand L, Soize S, Tisserand M, Rosso C, Piotin M, Boulouis G, Oppenheim C, Naggara O, Bracard S, Clarencon F, Lapergue B, Bourcier R; ASTER and the THRACE Trials Investigators. Clot Burden Score and Collateral Status and Their Impact on Functional Outcome in Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2021 Jan;42(1):42-48. doi: 10.3174/ajnr.A6865. Epub 2020 Nov 12.
Results Reference
derived
PubMed Identifier
31519778
Citation
Boulouis G, Bricout N, Benhassen W, Ferrigno M, Turc G, Bretzner M, Benzakoun J, Seners P, Personnic T, Legrand L, Trystram D, Rodriguez-Regent C, Charidimou A, Rost NS, Bracard S, Cordonnier C, Oppenheim C, Naggara O, Henon H. White matter hyperintensity burden in patients with ischemic stroke treated with thrombectomy. Neurology. 2019 Oct 15;93(16):e1498-e1506. doi: 10.1212/WNL.0000000000008317. Epub 2019 Sep 13.
Results Reference
derived
PubMed Identifier
30744542
Citation
Provost C, Soudant M, Legrand L, Ben Hassen W, Xie Y, Soize S, Bourcier R, Benzakoun J, Edjlali M, Boulouis G, Raoult H, Guillemin F, Naggara O, Bracard S, Oppenheim C. Magnetic Resonance Imaging or Computed Tomography Before Treatment in Acute Ischemic Stroke. Stroke. 2019 Mar;50(3):659-664. doi: 10.1161/STROKEAHA.118.023882.
Results Reference
derived
PubMed Identifier
28916667
Citation
Achit H, Soudant M, Hosseini K, Bannay A, Epstein J, Bracard S, Guillemin F; THRACE Investigators. Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial. Stroke. 2017 Oct;48(10):2843-2847. doi: 10.1161/STROKEAHA.117.017856. Epub 2017 Sep 15.
Results Reference
derived
PubMed Identifier
27567239
Citation
Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15(11):1138-47. doi: 10.1016/S1474-4422(16)30177-6. Epub 2016 Aug 23. Erratum In: Lancet Neurol. 2016 Nov;15(12):1203.
Results Reference
derived
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Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke
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