Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

Phase 3

Terminated

• Conditions: Stroke, Ischemic
• Interventions: Drug: Tenecteplase

• Registration Number: NCT05657457
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-10
• Study First Posted: 2022-12-20
• Study Start: 2023-03-21
• Status Verified: 2025-03
• Primary Completion: 2025-03-18
• Study Completion: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNK group	Tenecteplase	-

Primary Outcome Measures

Name	Time	Method
proportion of favorable functional outcome	Day 90	favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3

Secondary Outcome Measures

Name	Time	Method
change in modified Rankin Score (mRS) compared with premorbid mRS	Day 90	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
change in National Institute of Health stroke scale (NIHSS)	24 (-6/+24) hours	NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit
proportion of early neurological improvement	24 (-6/+24) hours	early neurological improvement is defined as a NIHSS decrease ≥4
cerebral edema	24 (-6/+24) hours	cerebral edema was measure by the mount of midline shift of the brain on neuroimaging
all-cause mortality	10 days
the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events	Day 90
proportion of sympomatic intracranial hemorrhage	24 (-6/+24) hours	sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
proportion of intraparenchymal hemorrhage	24 (-6/+24) hours	intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
the proportion of patients with modified Rankin Score (mRS) 0 to 2	Day 90	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
proportion of patients with an improved modified thrombolysis in cerebral infarction score	immediately after intraarterial TNK administration or at the end of endovascular treatment
the proportion of patients with modified Rankin Score (mRS) 0 to 1	Day 90	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
ordinal distribution of modified Rankin Score (mRS)	Day 90	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
change in the cerebral circulation time	immediately after tenecteplase
the percentage of severe adverse events	24 (-6/+24) hours
the number of tenecteplase infusions interrupted due to suspected active bleeding	during endovascular treatment (up to 2 hours)

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China