Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization … (NCT05657457) | Clinical Trial Compass
TerminatedPhase 3
Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)
Stopped: The interim analysis showed the potential harm of intra-arterial TNK.
China145 participantsStarted 2023-03-21
Plain-language summary
The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18
* Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
* National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
* Successful recanalization (mTICI 2b-3) after endovascular treatment;
* PC-ASPECTS ≥ 6 on CT;
* Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
* Modified Rankin Scale score before stroke onset ≤ 3;
* Signed informed consent by patient or their legally authorized representative.
Exclusion Criteria:
* baseline PC ASPECTS \< 5 on CT;
* More than six retrieval attempts in the same vessel;
* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
* Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (\<100000/mm3), or INR \> 1.7;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* After recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
* Patients with contraindication or allergic to any ingredient of drugs in our study
* Pregnancy, plan to get pregnant or during lactation
* The estimated life expectan…
What they're measuring
1
proportion of favorable functional outcome
Timeframe: Day 90
Trial details
NCT IDNCT05657457
SponsorGeneral Hospital of Shenyang Military Region