Tenecteplase Plus Butylphthalide for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Study Details
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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tenecteplase group intravenous thrombolysis with tenecteplase, combined with butylphthalide. |
Drug: Tenecteplase
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)
|
| Other: Control group standard stroke care based on national guideline |
Drug: Tenecteplase
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)
|
Outcome Measures
Primary Outcome Measures
- proportion of modified Rankin Scale (mRS) 0-1 [90±7 days]
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 [90±7 days]
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) [90±7 days]
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 [24 (-6/+12) hours]
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 [10±2 days]
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
- occurrence of early neurological improvement (ENI) [24 (-6/+12) hours]
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
- new stroke or other vascular event(s) [90±7 days]
- all-cause mortality [90±7 days]
- symptomatic intracranial hemorrhage [24 (-6/+12) hours]
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
- intracranial hemorrhage [24 (-6/+12) hours]
any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification
- major systemic bleeding event [24 (-6/+12) hours]
- any bleeding event [24 (-6/+12) hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 year
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Acute ischemic stroke confirmed by non-contrast computed tomography;
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The time from last known well to treatment: 4.5 - 6 hours;
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NIHSS ≥ 4 at randomization;
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First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
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Signed informed consent.
Exclusion Criteria:
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Pre-stroke disability (mRS≥3);
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Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
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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;
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Pregnancy;
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Allergy to test drugs;
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Comorbidity with other serious diseases;
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Participating in other clinical trials within 3 months;
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Patients not suitable for the study considered by researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, General Hospital of Northern Theater Command | Shenyang | China | 110016 |
Sponsors and Collaborators
- General Hospital of Shenyang Military Region
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Y (2023) 144