A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial. Randomization will be 1:1 according to reperfusion treatment modalities: (A) Intravenous thrombolysis with tenecteplase (0.25 mg/kg) plus mechanical thrombectomy vs. (B) Intravenous thrombolysis with alteplase (0.9 mg/kg) plus mechanical thrombectomy. For the primary outcome, the subjects will be followed up within 90 days after randomization. The primary outcome will be the Functional independence defined as modified Rankin Score ≤ 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
850
Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy
Alteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGmRS ≤ 2 at 90 days or no change from baseline
mRS ≤ 2 at 90 days or no change from baseline
Time frame: 90 days from baseline
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
Time frame: initial angiogram
mRS at 90 days from baseline
mRS at 90 days from baseline
Time frame: 90 days from baseline
mRS 0-1 at 90 days or no change from baseline
mRS 0-1 at 90 days or no change from baseline
Time frame: 90 days from baseline
Barthel index at 90 days from baseline
Barthel index at 90 days from baseline
Time frame: 90 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
Time frame: 3 days from baseline
Change of NIHSS at 1、3、7 days from baseline
Change of NIHSS at 1、3、7 days from baseline
Time frame: 1、3、7 days from baseline
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