Stroke, Ischemic
Conditions
Brief summary
To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.
Interventions
DRUGTNK-Tissue Plasminogen Activator
0.25 mg TNK thrombolysis
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 80 Years
Healthy volunteers
No
Inclusion criteria
* age: 18-80; * ischemic stroke confirmed by brain CT or MRI * the time from onset to treatment: 4.5-6 hours * NIHSS≥4 * prestroke mRS≤1 * signed informed consent
Exclusion criteria
* prestroke mRS≥2 * planned endovascular treatment * planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion * any contraindiction of intravenous thrombolysis * other unsuitable conditions judged by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptomatic intracerebral hemorrhage | 36 hours | any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of favourable prognosis (mRS 0-2) | Day 90 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome |
| Distribution of modified Rankin Score | Day 90 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome |
| Changes in National Institute of Health stroke scale (NIHSS) | 24 hours, 2 weeks | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome |
| The proportion of excellent prognosis (mRS 0-1) | Day 90 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome |
| any cerebral microbleeding(CMB) | 48 hours | CMB is measured by SWI sequence |
| infarct volume | 48 hours | infarct volume is measured by DWI sequence |
| proportion of death | Day 90 | death due to any cause |
| any intracerebral hemorrhage | 36 hours | the evidence of bleeding on the head CT scan |
Countries
China
Outcome results
None listed