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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Directeur de la Recherche et de l'Innovation, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01062698
First received: February 3, 2010
Last updated: March 20, 2012
Last verified: March 2012

February 3, 2010
March 20, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
Modified Rankin Score (mRs ) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01062698 on ClinicalTrials.gov Archive Site
  • Quality of Life (Euroqol EQ-5D) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Barthel Score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Cerebral Stroke
  • Cerebrovascular Accident
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
France
 
NCT01062698
2009-A00753-54
Not Provided
Directeur de la Recherche et de l'Innovation, Central Hospital, Nancy, France
Central Hospital, Nancy, France
Not Provided
Principal Investigator: Serge Bracard, Pr Central Hospital Nancy France (HNF)
Central Hospital, Nancy, France
March 2012

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