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

Phase 2

Completed

• Conditions: Stroke, Ischemic
• Interventions: Drug: TNK-Tissue Plasminogen Activator

• Registration Number: NCT05189509
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-12
• Study Start: 2022-02-11
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNK group	TNK-Tissue Plasminogen Activator	intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg
control group	TNK-Tissue Plasminogen Activator	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
any intracerebral hemorrhage	36 hours	the evidence of bleeding on the head CT scan
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

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China