Stroke, Ischemic
Conditions
Keywords
thrombolysis
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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Interventions
DRUGTenecteplase
intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 year * Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators; * 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≤1); * Uncertainty over the benefits and risks of thrombolysis by researcher; * Signed informed consent.
Exclusion criteria
* Pre-stroke disability (mRS≥2); * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 (sICH) | 24 (-6/+12) hours | sICH is defined as parenchymal hematoma type 1 or 2 (PH1 or PH2), remote intraparenchymal hematoma (RIH), subarachnoid hemorrhage, or intraventricular hemorrhage on head CT/MRI scan causally associated with clinically significant neurological deterioration (NIHSS score ≥4 point increase) in the opinion of the clinical investigator or independent safety monitor. |
| 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 | — |
Countries
China
Outcome results
None listed