Back to resultsTenecteplase Plus Butylphthalide for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Primary Purpose
Stroke, Ischemic
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tenecteplase
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring thrombolysis
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 year Acute ischemic stroke confirmed by non-contrast computed tomography; The time from last known well to treatment: 4.5 - 6 hours; NIHSS ≥ 4 at randomization; First stroke onset or past stroke without obvious neurological deficit (mRS≤2); Signed informed consent. Exclusion Criteria: Pre-stroke disability (mRS≥3); Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion; Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of <100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose < 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures; Pregnancy; Allergy to test drugs; Comorbidity with other serious diseases; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.
Sites / Locations
- Department of Neurology, General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Tenecteplase group
Control group
Arm Description
intravenous thrombolysis with tenecteplase, combined with butylphthalide.
standard stroke care based on national guideline
Outcomes
Primary Outcome Measures
proportion of modified Rankin Scale (mRS) 0-1
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Secondary Outcome Measures
proportion of modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
new stroke or other vascular event(s)
all-cause mortality
symptomatic intracranial hemorrhage
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
intracranial hemorrhage
any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification
major systemic bleeding event
any bleeding event
Full Information
NCT ID
NCT06010628
First Posted
August 20, 2023
Last Updated
August 23, 2023
Sponsor
General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT06010628
Brief Title
Tenecteplase Plus Butylphthalide for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Official Title
Tenecteplase Plus Butylphthalide for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
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
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
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) plus Dl-3-n-Butylphthalide (NBP) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK plus NBP for AIS within 4.5 to 6 hours of onset.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
thrombolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tenecteplase group
Arm Type
Experimental
Arm Description
intravenous thrombolysis with tenecteplase, combined with butylphthalide.
Arm Title
Control group
Arm Type
Other
Arm Description
standard stroke care based on national guideline
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Description
intravenous butylphthalide (NBP) (25mg, 100 mL sodium chloride injection) and tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg), followed by intravenous NBP (25mg, 100 mL sodium chloride injection, two times daily for 10±2 days). This will be later followed by oral soft NBP capsules (0.2 g, three times daily for the next 80±2 days)
Primary Outcome Measure Information:
Title
proportion of modified Rankin Scale (mRS) 0-1
Description
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
proportion of modified Rankin Scale (mRS) 0-2
Description
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Title
ordinal distribution of modified Rankin Scale (mRS)
Description
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Title
change in National Institute of Health stroke scale (NIHSS) score
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time Frame
24 (-6/+12) hours
Title
change in National Institute of Health stroke scale (NIHSS) score
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time Frame
10±2 days
Title
occurrence of early neurological improvement (ENI)
Description
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
Time Frame
24 (-6/+12) hours
Title
new stroke or other vascular event(s)
Time Frame
90±7 days
Title
all-cause mortality
Time Frame
90±7 days
Title
symptomatic intracranial hemorrhage
Description
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
Time Frame
24 (-6/+12) hours
Title
intracranial hemorrhage
Description
any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification
Time Frame
24 (-6/+12) hours
Title
major systemic bleeding event
Time Frame
24 (-6/+12) hours
Title
any bleeding event
Time Frame
24 (-6/+12) hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 year
Acute ischemic stroke confirmed by non-contrast computed tomography;
The time from last known well to treatment: 4.5 - 6 hours;
NIHSS ≥ 4 at randomization;
First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
Signed informed consent.
Exclusion Criteria:
Pre-stroke disability (mRS≥3);
Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of <100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose < 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures;
Pregnancy;
Allergy to test drugs;
Comorbidity with other serious diseases;
Participating in other clinical trials within 3 months;
Patients not suitable for the study considered by researcher.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tenecteplase Plus Butylphthalide for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
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