THRACE Trial: Bridging Thrombectomy After Alteplase
In alteplase-eligible patients with proximal anterior circulation LVO and NIHSS 10 to 25 treated within 5 hours, does adding mechanical thrombectomy to IV alteplase improve functional independence at 3 months compared with alteplase alone?
Bracard et al. (Lancet Neurol 2016) · doi:10.1016/S1474-4422(16)30177-6 · 414 patients
Population
Included
- Age 18 to 80 years
- Acute ischemic stroke with NIHSS 10 to 25
- Proximal anterior circulation occlusion (intracranial ICA, M1, or upper basilar) confirmed by CTA or MRA
- IV alteplase started within 4 hours of symptom onset (0.9 mg/kg, max 90 mg)
- Mechanical thrombectomy able to begin within 5 hours of symptom onset
- 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
Excluded
- Standard contraindications to IV alteplase
- Pre-stroke mRS greater than 1
- Intracranial hemorrhage on baseline imaging
- Established large infarct on baseline CT or MRI
- Severe comorbid disease limiting expected survival
- 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
Source: ClinicalTrials.gov NCT01062698· Retrieved 2026-06-08
Primary Outcome — mRS 0-2 at 3 Months
All randomized patients (proximal anterior circulation LVO, NIHSS 10 to 25)
mRS 0-2 at 3 Months
Study Arms
- Agent
- IV alteplase 0.9 mg/kg PLUS mechanical thrombectomy with an operator-selected device from the trial's regularly-updated list of CE-marked/approved devices (stent retrievers such as Solitaire and Trevo). No single brand was mandated.
- Dose
- Alteplase 0.9 mg/kg (maximum 90 mg); optional complementary intra-arterial alteplase up to 0.3 mg/kg at end of thrombectomy for persistent distal occlusion
- Route
- IV alteplase + endovascular thrombectomy
- Frequency
- Alteplase: 10% bolus then remainder over 60 min, started <4 h from onset. Thrombectomy: single procedure, initiated <5 h from onset. From Oct 12, 2012, thrombectomy could begin during thrombolysis.
- Duration
- Alteplase 60-min infusion; thrombectomy one-time procedure
- Co-interventions
- Conscious sedation or general anaesthesia at operator discretion. Thrombectomy performed only if mTICI <2 at angiography.
From Bracard Lancet Neurol 2016 p.1139-1140. KEY NUANCE: if NIHSS decreased ≥4 after thrombolysis, angiography/thrombectomy were CANCELLED; 59/204 allocated IVTMT did not receive thrombectomy. Operators required ≥5 prior interventions with the chosen device. Source: NCT01062698.
- Agent
- IV alteplase (no thrombectomy)
- Dose
- 0.9 mg/kg (maximum 90 mg)
- Route
- IV
- Frequency
- 10% bolus then remainder over 60 min, started <4 h from onset
- Duration
- 60-minute infusion
- Co-interventions
- Best medical care per standard practice; no endovascular intervention
Control = standard IV thrombolysis ALONE (NOT thrombectomy alone). Alteplase identical to the intervention arm; only difference is added thrombectomy. Time window initially <3 h, extended to <4 h by May 14, 2011 amendment. Source: Bracard Lancet Neurol 2016 p.1139.
Trial Design
Type
- Randomized controlled trial across 26 French centers
- IV alteplase alone vs IV alteplase plus mechanical thrombectomy
- Proximal cerebral artery occlusion
- IVT within 4 hours and thrombectomy within 5 hours
Timeline
Enrolled 2010-2015
N
414
Enrollment
French multicenter RCT enrolling 414 patients across 26 centers between 2010 and 2015 (Bracard Lancet Neurol 2016).
ClinicalTrials.gov
NCT01062698Bedside Pearl
For an alteplase-eligible patient with proximal anterior circulation LVO and NIHSS 10 to 25 inside the early window, THRACE supports starting IV alteplase and proceeding to thrombectomy without delay. The 53% versus 42% gain (NNT 9) is consistent with the broader 2015 stent-retriever evidence base.