The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.
The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
550
intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment
endovascular treatment
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The Second Hospital of Jiaozuo
Jiaozuo, Henan, China
Wuhan No. 1 Hospital
Wuhan, Hubei, China
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan, China
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
functional independence
Time frame: 90 days
Substantial reperfusion at initial angiogram
evaluate effect of tenecteplase on reperfusion
Time frame: within 5 minutes at initial angiogram
Successful reperfusion at end-of-procedure angiography
evaluate vascular patency after thrombectomy
Time frame: 15 minutes after initial angiogram
First-pass reperfusion
defined as Expanded Treatment in Cerebral Infarction ≥2c after the first thrombectomy pass
Time frame: After artery puncture, but before thrombectomy
Modified first-pass reperfusion
defined as Expanded Treatment in Cerebral Infarction ≥2b after the first thrombectomy pass
Time frame: After artery puncture, but before thrombectomy
National Institutes of Health Stroke Scale (NIHSS) score
Neurological status
Time frame: 5 to 7 days or discharge
modified Rankin scale score
disability level
Time frame: 90 days
Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)
excellent outcome
Time frame: 90 days
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Xiangtan Central Hospital
Xiangtan, Hunan, China
The 904th Hospital of CPLA
Wuxi, Jiangsu, China
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)
ambulatory or bodily needs-capable or better
Time frame: 90 days
Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Health-related quality of life
Time frame: 90 days
Any radiologic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage
Time frame: within 48 hours after endovascular treatment
Symptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage (Heidelberg classification)
Time frame: within 48 hours after endovascular treatment
Mortality within 90 days
evaluate death rate of the two treatment groups
Time frame: 90 days
Procedural-related complications
evaluate complications
Time frame: within 90 days
Severe adverse events
evaluate any adverse events
Time frame: within 90 days