The CHOICE study suggested that the use of adjunct intra-arterial alteplase after successful endovascular reperfusion in large vessel occlusion acute ischemic strokes may result in a greater likelihood of excellent neurological outcome at 90 days. However, CHOICE was a phase-2 trial and almost exclusively enrolled anterior circulation occlusions. Therefore, data on the safety and efficacy of post-endovascular reperfusion IAT in posterior circulation stroke is lacking. In general, anterior circulation strokes are associated with a higher risk of ICH than posterior circulation strokes. Therefore, we believe it might be safer to perform post-endovascular reperfusion IAT posterior circulation stroke. Also, there are more perforator artery in the posterior circulation, IAT would be more likely to show its benefit. Therefore, we would like to explore IA rt-PA for posterior circulation stroke after successful MT in our RCT. In this study, one interim analysis will be performed when the enrollment volume reaches 50% of the total sample size (188 cases). DSMB will determine the premature termination or continuity of research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
247
For patients in the successful MT plus intra-arterial alteplase group, after successful recanalization, neurointerventionalists administered intra-arterial thrombolysis with alteplase according to protocol. The angiographic scores will be assessed immediately after intra-arterial thrombolysis.
Xuanwu Hospital, Capital Medical University.
Beijing, China
Rate of modified Rankin Scale (mRS) score of 0-2
The mRS score range from 0 (no disability) to 6 (death)
Time frame: 90 days (±7 days) after randomization
Change of eTICI
Change of eTICI after intra-arterial thrombolysis
Time frame: Before intra-arterial thrombolysis vs. immediately after the completion of intra-arterial thrombolysis
Rate of mRS score of 0-3
The mRS score range from 0 (no disability) to 6 (death)
Time frame: 90 days (±7 days) after randomization
Proportional distribution of modified Rankin Score
The mRS score range from 0 (no disability) to 6 (death)
Time frame: 90 days (±7 days) after randomization
Improvement of the National Institutes of Health Stroke Scale (NIHSS) score
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Time frame: 48 hours (±12 hours) after randomization
Rate of early neurological improvement
The NIHSS score 0-1 or decrease ≥8 from baseline NIHSS
Time frame: 48 hours (±12 hours) after randomization
Improvement of the NIHSS score
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Time frame: 7 days (±1 days) after randomization or discharge
EQ-5D-5L
The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0.
Time frame: 90 days (±7 days) after randomization
Barthel Index
The Barthel Index range from 0 (severe disability) to 100 (no disability)
Time frame: 90 days (±7 days) after randomization
All-cause mortality
Death defined as a mRS score of 6
Time frame: 90 days (±7 days) after randomization
Rate of symptomatic intracranial hemorrhage (sICH)
The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration.
Time frame: Within 48 hours after randomization
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