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Cerebral StrokeTHRACENCT01062698

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

A study testing Alteplase (rt-PA)/Actilyse and Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) in people with Cerebral Stroke and Cerebrovascular Accident, run by Central Hospital, Nancy, France at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cerebral Stroke, Cerebrovascular Accident
What is being tested?
Alteplase (rt-PA)/Actilyse and Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteFrance
Study dates
Jun 2010to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Central Hospital Nancy (Central HNF)

    Nancy

Other trials in France

About this study

Official title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis

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.

Being tested
Alteplase (rt-PA)/Actilyse, Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Keywords
mechanical Thrombectomy, CVA (Cerebrovascular Accident), Cerebrovascular Accident, Acute
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alteplase (rt-PA)/ActilyseDrug

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

  • Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)Procedure or surgery

    Mechanic thrombectomy

Study groups in NCT01062698
Study groupRoleWhat they receive
IV thrombolysis + thrombectomyActive comparatorNot described
Receives: Drug: Alteplase (rt-PA)/Actilyse; Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
IV thrombolysisActive comparatorNot described
Receives: Drug: Alteplase (rt-PA)/Actilyse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Score (mRs )

    Measured: 3 months after treatment

Secondary outcomes (2)

  1. Quality of Life (Euroqol EQ-5D)

    Measured: 3 months after treatment

  2. Barthel Score

    Measured: 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2015
  4. Study completionMar 2016

Why it stopped: Efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01062698
Sponsor's protocol ID
2009-A00753-54
Acronym
THRACE
Status last verified
Jul 2017
First submitted
3 Feb 2010
Last updated
21 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 38355868

  • 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.

    PubMed 35698971

  • 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.

    PubMed 34103393

  • 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.

    PubMed 33184069

  • 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.

    PubMed 31519778

  • 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.

    PubMed 30744542

  • 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.

    PubMed 28916667

  • 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.

    PubMed 27567239

Questions about this trial

What is this clinical trial studying?

A study testing Alteplase (rt-PA)/Actilyse and Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) in people with Cerebral Stroke and Cerebrovascular Accident, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Score (mRs ) (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01062698, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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