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Completed

NCT Number: NCT05189509

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNK-Tissue Plasminogen Activator

Drug

0.25 mg TNK thrombolysis

Primary outcomes

  1. symptomatic intracerebral hemorrhage

    Time frame: 36 hours

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

Secondary outcomes

  1. The proportion of excellent prognosis (mRS 0-1)

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

  2. The proportion of favourable prognosis (mRS 0-2)

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

  3. Distribution of modified Rankin Score

    Time frame: Day 90

    the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

  4. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 24 hours, 2 weeks

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

  5. any intracerebral hemorrhage

    Time frame: 36 hours

    the evidence of bleeding on the head CT scan

  6. any cerebral microbleeding(CMB)

    Time frame: 48 hours

    CMB is measured by SWI sequence

  7. infarct volume

    Time frame: 48 hours

    infarct volume is measured by DWI sequence

  8. proportion of death

    Time frame: Day 90

    death due to any cause

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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