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Efficacy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV thrombolysis + thrombectomy | Active Comparator |
| |
| IV thrombolysis | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase (rt-PA)/Actilyse | Drug | Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score (mRs ) | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (Euroqol EQ-5D) | 3 months after treatment | |
| Barthel Score | 3 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge Bracard, Pr | Central Hospital Nancy France (HNF) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital Nancy (Central HNF) | Nancy | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38355868 | Derived | Agbonon R, Forestier G, Bricout N, Benhassen W, Turc G, Bretzner M, Pasi M, Benzakoun J, Seners P, Derraz I, Legrand L, Trystram D, Rodriguez-Regent C, Charidimou A, Rost NS, Bracard S, Cordonnier C, Eker OF, Oppenheim C, Naggara O, Henon H, Boulouis G. Cerebral microbleeds and risk of symptomatic hemorrhagic transformation following mechanical thrombectomy for large vessel ischemic stroke. J Neurol. 2024 May;271(5):2631-2638. doi: 10.1007/s00415-024-12205-7. Epub 2024 Feb 14. | |
| 35698971 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| C113049 | Solitaire composite resin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) | Procedure | Mechanic thrombectomy |
|
| Derived |
| 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. |
| 34103393 | Derived | 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. |
| 33184069 | Derived | 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. |
| 31519778 | Derived | 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. |
| 30744542 | Derived | 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. |
| 28916667 | Derived | 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. |
| 27567239 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |