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

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TNK-Tissue Plasminogen Activator
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNK group

control group

Arm Description

intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
any intracerebral hemorrhage
the evidence of bleeding on the head CT scan
any cerebral microbleeding(CMB)
CMB is measured by SWI sequence
infarct volume
infarct volume is measured by DWI sequence
proportion of death
death due to any cause

Full Information

First Posted
December 29, 2021
Last Updated
January 12, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT05189509
Brief Title
EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNK group
Arm Type
Experimental
Arm Description
intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TNK-Tissue Plasminogen Activator
Intervention Description
0.25 mg TNK thrombolysis
Primary Outcome Measure Information:
Title
symptomatic intracerebral hemorrhage
Description
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 Outcome Measure Information:
Title
The proportion of excellent prognosis (mRS 0-1)
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Title
The proportion of favourable prognosis (mRS 0-2)
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Title
Distribution of modified Rankin Score
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Time Frame
24 hours, 2 weeks
Title
any intracerebral hemorrhage
Description
the evidence of bleeding on the head CT scan
Time Frame
36 hours
Title
any cerebral microbleeding(CMB)
Description
CMB is measured by SWI sequence
Time Frame
48 hours
Title
infarct volume
Description
infarct volume is measured by DWI sequence
Time Frame
48 hours
Title
proportion of death
Description
death due to any cause
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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