Xuanwu Hospital, Capital Medical University.
Beijing, 100053, China
NCT Number: NCT05897554
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, 100053, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Intraarterial alteplase recombinant tissue plasminogen activator (r-tPA)
Time frame: 90 days (±7 days) after randomization
The mRS score range from 0 (no disability) to 6 (death)
Time frame: Before intra-arterial thrombolysis vs. immediately after the completion of intra-arterial thrombolysis
Change of eTICI after intra-arterial thrombolysis
Time frame: 90 days (±7 days) after randomization
The mRS score range from 0 (no disability) to 6 (death)
Time frame: 90 days (±7 days) after randomization
The mRS score range from 0 (no disability) to 6 (death)
Time frame: 48 hours (±12 hours) after randomization
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Time frame: 48 hours (±12 hours) after randomization
The NIHSS score 0-1 or decrease ≥8 from baseline NIHSS
Time frame: 7 days (±1 days) after randomization or discharge
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Time frame: 90 days (±7 days) after randomization
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
The Barthel Index range from 0 (severe disability) to 100 (no disability)
Time frame: 90 days (±7 days) after randomization
Death defined as a mRS score of 6
Time frame: Within 48 hours after randomization
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.
Xuanwu Hospital, Beijing
Other
Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation (IAT-TOP)
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