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 Stopped: Efficacy
- Alteplase (rt-PA)/Actilyse Drug
Intervention Desc: Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection. ARM 1: Kind: Experimental Label: IV thrombolysis + thrombectomy ARM 2: Kind: Experimental Label: IV thrombolysis
- Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE) Procedure
Intervention Desc: Mechanic thrombectomy ARM 1: Kind: Experimental Label: IV thrombolysis + thrombectomy
- Allocation: Randomized
- Masking: Single Blind (Investigator)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Score (mRs )||3 months after treatment||Yes|
|Secondary||Quality of Life (Euroqol EQ-5D)||3 months after treatment||Yes|
|Secondary||Barthel Score||3 months after treatment||Yes|