NCT01062698

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

5.5 years

First QC Date

February 3, 2010

Last Update Submit

July 20, 2017

Conditions

Cerebral StrokeCerebrovascular Accident

Keywords

mechanical ThrombectomyCVA (Cerebrovascular Accident)Cerebrovascular Accident, Acute

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Score (mRs )

    3 months after treatment

Secondary Outcomes (2)

  • Quality of Life (Euroqol EQ-5D)

    3 months after treatment

  • Barthel Score

    3 months after treatment

Study Arms (2)

IV thrombolysis + thrombectomy

ACTIVE COMPARATOR
Drug: Alteplase (rt-PA)/ActilyseProcedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

IV thrombolysis

ACTIVE COMPARATOR
Drug: Alteplase (rt-PA)/Actilyse

Interventions

Alteplase (rt-PA)/ActilyseDRUG

Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

IV thrombolysisIV thrombolysis + thrombectomy
Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)PROCEDURE

Mechanic thrombectomy

IV thrombolysis + thrombectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<=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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital Nancy (Central HNF)

Nancy, France

Location

Related Publications (8)

  • 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.

    PMID: 38355868DERIVED

  • 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.

    PMID: 35698971DERIVED

  • 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.

    PMID: 34103393DERIVED

  • 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.

    PMID: 33184069DERIVED

  • 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.

    PMID: 31519778DERIVED

  • 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.

    PMID: 30744542DERIVED

  • 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.

    PMID: 28916667DERIVED

  • 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.

    PMID: 27567239DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen ActivatorSolitaire composite resin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Serge Bracard, Pr

    Central Hospital Nancy France (HNF)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Serge BRACARD

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

FR(1)