Clinical trial NCT05657457: Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)
Official title: Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
Collaborators: name: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
First posted: 2022-12-20
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 expectancy is less than 6 months due to other serious diseases;
* Other conditions unsuitable for this clinical study assessed by researcher.

Primary outcomes:
measure: proportion of favorable functional outcome
timeFrame: Day 90
Secondary outcomes:
measure: proportion of patients with an improved modified thrombolysis in cerebral infarction score
timeFrame: immediately after intraarterial TNK administration or at the end of endovascular treatment
measure: the proportion of patients with modified Rankin Score (mRS) 0 to 1
timeFrame: Day 90
measure: the proportion of patients with modified Rankin Score (mRS) 0 to 2
timeFrame: Day 90
measure: ordinal distribution of modified Rankin Score (mRS)
timeFrame: Day 90
measure: change in modified Rankin Score (mRS) compared with premorbid mRS
timeFrame: Day 90
measure: change in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 (-6/+24) hours
measure: proportion of early neurological improvement
timeFrame: 24 (-6/+24) hours
measure: change in the cerebral circulation time
timeFrame: immediately after tenecteplase
measure: the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events
timeFrame: Day 90
measure: proportion of sympomatic intracranial hemorrhage
timeFrame: 24 (-6/+24) hours
measure: proportion of intraparenchymal hemorrhage
timeFrame: 24 (-6/+24) hours
measure: the percentage of severe adverse events
timeFrame: 24 (-6/+24) hours
measure: cerebral edema
timeFrame: 24 (-6/+24) hours
measure: all-cause mortality
timeFrame: 10 days
measure: the number of tenecteplase infusions interrupted due to suspected active bleeding
timeFrame: during endovascular treatment (up to 2 hours)
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: