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

This study is currently recruiting participants.
Verified March 2012 by Central Hospital, Nancy, France
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
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Stroke
Cerebrovascular Accident
 Drug: Alteplase (rt-PA)/Actilyse
Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Modified Rankin Score (mRs ) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 480
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV thrombolysis + thrombectomy 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 Drug: Alteplase (rt-PA)/Actilyse
Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062698

Locations
France
Central Hospital Nancy (Central HNF) Recruiting
Nancy, France
Contact: Serge Pr BRACARD     00333 83851773     s.bracard@chu-nancy.fr    
Principal Investigator: Serge Bracard, Pr            
Principal Investigator: Xavier Ducrocq            
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Serge Bracard, Pr Central Hospital Nancy France (HNF)
  More Information

No publications provided

Responsible Party: Directeur de la Recherche et de l'Innovation, Professor Serge BRACARD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01062698     History of Changes
Other Study ID Numbers: 2009-A00753-54
Study First Received: February 3, 2010
Last Updated: March 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
mechanical Thrombectomy
CVA (Cerebrovascular Accident)
Cerebrovascular Accident, Acute

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013