Back to resultsIntra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
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 years; Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset; The modified Rankin Scale (mRS) score before onset ≤ 2; ASPECTS 6 or greater on CT Signed informed consent. Exclusion Criteria: hemorrhagic stroke; Tandem occlusion; Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3); Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); Patients with contraindication or allergic to any ingredient of drugs in our study; Pregnancy, or plan to get pregnant or during active lactation; Suspected septic embolus or infective endocarditis The estimated life expectancy is less than 6 months due to other serious diseases; Other conditions unsuitable for this clinical study as 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 outcome
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
Secondary Outcome Measures
proportion of excellent outcome
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3
Distribution of modified Rankin Scale (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 cerebral circulation time after intervention
occurrence rate of early neurological improvement
early neurological improvement was defined as a 4 point or greater decrease in NIHSS
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
occurrence rate of symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.
occurrence rate of parenchymal hemorrhage
parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
percentage of severe adverse events
cerebral edema
cerebral edema was measured as the amount of midline shift of the brain on neuroimaging
death due to all causes
occurrence rate of the distal emboli after first pass
The emboli means occlusion of the distal artery determined by DSA.
occurrence rate of extracranial hemorrhage
extracranial hemorrhage means other bleeding events except intracranial hemorrhage
Full Information
NCT ID
NCT05657444
First Posted
December 2, 2022
Last Updated
March 21, 2023
Sponsor
General Hospital of Shenyang Military Region
Collaborators
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
1. Study Identification
Unique Protocol Identification Number
NCT05657444
Brief Title
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
Official Title
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study
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
May 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
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).
The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
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
372 (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 during endovascular treatment
Primary Outcome Measure Information:
Title
proportion of favorable outcome
Description
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
proportion of excellent outcome
Description
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1
Time Frame
Day 90
Title
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
Description
Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3
Time Frame
immediately after the first-pass or final pass of endovascular treatment
Title
Distribution of modified Rankin Scale (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 cerebral circulation time after intervention
Time Frame
immediately after endovascular treatment
Title
occurrence rate of early neurological improvement
Description
early neurological improvement was defined as a 4 point or greater decrease in NIHSS
Time Frame
24 (-6/+24) hours
Title
change in National Institute of Health stroke scale (NIHSS)
Description
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Time Frame
24 (-6/+24) hours
Title
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Time Frame
Day 90
Title
occurrence rate of symptomatic intracranial hemorrhage
Description
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.
Time Frame
24 (-6/+24) hours
Title
occurrence rate of parenchymal hemorrhage
Description
parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
Time Frame
24 (-6/+24) hours
Title
percentage of severe adverse events
Time Frame
24 (-6/+24) hours
Title
cerebral edema
Description
cerebral edema was measured as the amount of midline shift of the brain on neuroimaging
Time Frame
24 (-6/+24) hours
Title
death due to all causes
Time Frame
Day 7 or during hospitalization
Title
occurrence rate of the distal emboli after first pass
Description
The emboli means occlusion of the distal artery determined by DSA.
Time Frame
immediately after first pass
Title
occurrence rate of extracranial hemorrhage
Description
extracranial hemorrhage means other bleeding events except intracranial hemorrhage
Time Frame
24 (-6/+24) hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years;
Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
The modified Rankin Scale (mRS) score before onset ≤ 2;
ASPECTS 6 or greater on CT
Signed informed consent.
Exclusion Criteria:
hemorrhagic stroke;
Tandem occlusion;
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
Patients with contraindication or allergic to any ingredient of drugs in our study;
Pregnancy, or plan to get pregnant or during active lactation;
Suspected septic embolus or infective endocarditis
The estimated life expectancy is less than 6 months due to other serious diseases;
Other conditions unsuitable for this clinical study as 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
+862428897491
Email
zhaoziai@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
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