EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)

Stroke, Ischemic Clinical Trial

Official title:

EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189509
• Other study ID #: y (2021) 110
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

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