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

General Hospital of Shenyang Military Region100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Stroke, Ischemic

Interventions

TNK-Tissue Plasminogen Activator

0.25 mg TNK thrombolysis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

Outcomes

Primary Outcomes

symptomatic intracerebral hemorrhage

any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)

Time frame: 36 hours

Secondary Outcomes

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

Time frame: Day 90

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

Time frame: Day 90

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

Time frame: Day 90

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

Time frame: 24 hours, 2 weeks

any intracerebral hemorrhage

the evidence of bleeding on the head CT scan

Time frame: 36 hours

any cerebral microbleeding(CMB)

CMB is measured by SWI sequence

Time frame: 48 hours

infarct volume

infarct volume is measured by DWI sequence

Time frame: 48 hours

proportion of death

death due to any cause

Time frame: Day 90

Data from ClinicalTrials.gov

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