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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189509
Other study ID # y (2021) 110
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 11, 2022
Est. completion date December 28, 2022

Study information

Verified date January 2023
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 28, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TNK-Tissue Plasminogen Activator
0.25 mg TNK thrombolysis

Locations

Country Name City State
China Department of Neurology, General Hospital of Northern Theater Command Shenyang

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary symptomatic intracerebral hemorrhage any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score =4 points increase) 36 hours
Secondary The proportion of excellent prognosis (mRS 0-1) the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome Day 90
Secondary The proportion of favourable prognosis (mRS 0-2) the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome Day 90
Secondary Distribution of modified Rankin Score the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome Day 90
Secondary Changes in National Institute of Health stroke scale (NIHSS) the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome 24 hours, 2 weeks
Secondary any intracerebral hemorrhage the evidence of bleeding on the head CT scan 36 hours
Secondary any cerebral microbleeding(CMB) CMB is measured by SWI sequence 48 hours
Secondary infarct volume infarct volume is measured by DWI sequence 48 hours
Secondary proportion of death death due to any cause Day 90
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