An interventional study of Alteplase (rt-PA)/Actilyse and Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) in Cerebral Stroke and Cerebrovascular Accident, sponsored by Central Hospital, Nancy, France. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 412 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Alteplase (rt-PA)/Actilyse · Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
Drug: Alteplase (rt-PA)/Actilyse
Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.
Mechanic thrombectomy
Modified Rankin Score (mRs )
Time frame: 3 months after treatment
Quality of Life (Euroqol EQ-5D)
Time frame: 3 months after treatment
Barthel Score
Time frame: 3 months after treatment
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France