Back to resultsImproving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)
Primary Purpose
Stroke, Ischemic
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tenecteplase
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic
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.
Sites / Locations
- General Hospital of Northern Theater CommandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TNK group
control group
Arm Description
Outcomes
Primary Outcome Measures
proportion of favorable functional outcome
favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3
Secondary Outcome Measures
proportion of patients with an improved modified thrombolysis in cerebral infarction score
the proportion of patients with modified Rankin Score (mRS) 0 to 1
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.
the proportion of patients with modified Rankin Score (mRS) 0 to 2
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)
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 modified Rankin Score (mRS) compared with premorbid mRS
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)
NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit
proportion of early neurological improvement
early neurological improvement is defined as a NIHSS decrease ≥4
change in the cerebral circulation time
the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events
proportion of sympomatic intracranial hemorrhage
sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
proportion of intraparenchymal hemorrhage
intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
the percentage of severe adverse events
cerebral edema
cerebral edema was measure by the mount of midline shift of the brain on neuroimaging
all-cause mortality
the number of tenecteplase infusions interrupted due to suspected active bleeding
Full Information
NCT ID
NCT05657457
First Posted
December 2, 2022
Last Updated
March 22, 2023
Sponsor
General Hospital of Shenyang Military Region
Collaborators
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
1. Study Identification
Unique Protocol Identification Number
NCT05657457
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
Collaborators
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TNK group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Description
intra-arterial tenecteplase
Primary Outcome Measure Information:
Title
proportion of favorable functional outcome
Description
favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
proportion of patients with an improved modified thrombolysis in cerebral infarction score
Time Frame
immediately after intraarterial TNK administration or at the end of endovascular treatment
Title
the proportion of patients with modified Rankin Score (mRS) 0 to 1
Description
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.
Time Frame
Day 90
Title
the proportion of patients with modified Rankin Score (mRS) 0 to 2
Description
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.
Time Frame
Day 90
Title
ordinal distribution of modified Rankin Score (mRS)
Description
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.
Time Frame
Day 90
Title
change in modified Rankin Score (mRS) compared with premorbid mRS
Description
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.
Time Frame
Day 90
Title
change in National Institute of Health stroke scale (NIHSS)
Description
NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Time Frame
24 (-6/+24) hours
Title
proportion of early neurological improvement
Description
early neurological improvement is defined as a NIHSS decrease ≥4
Time Frame
24 (-6/+24) hours
Title
change in the cerebral circulation time
Time Frame
immediately after tenecteplase
Title
the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events
Time Frame
Day 90
Title
proportion of sympomatic intracranial hemorrhage
Description
sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage
Time Frame
24 (-6/+24) hours
Title
proportion of intraparenchymal hemorrhage
Description
intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
Time Frame
24 (-6/+24) hours
Title
the percentage of severe adverse events
Time Frame
24 (-6/+24) hours
Title
cerebral edema
Description
cerebral edema was measure by the mount of midline shift of the brain on neuroimaging
Time Frame
24 (-6/+24) hours
Title
all-cause mortality
Time Frame
10 days
Title
the number of tenecteplase infusions interrupted due to suspected active bleeding
Time Frame
during endovascular treatment (up to 2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
ShenYang
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zi-Ai Zhao
Phone
+862428897499
Email
zhaoziai@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)
We'll reach out to this number within 24 hrs