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

NCT05189509 | Completed Phase 2 DMC

• 1 other identifier: y (2021) 110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Day 90

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

  Day 90

• Distribution of modified Rankin Score

  Day 90

• Changes in National Institute of Health stroke scale (NIHSS)

  24 hours, 2 weeks

• any intracerebral hemorrhage

  36 hours

Study Arms (2)

TNK group

EXPERIMENTAL

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

Drug: TNK-Tissue Plasminogen Activator

control group

PLACEBO COMPARATOR

Drug: TNK-Tissue Plasminogen Activator

Interventions

TNK-Tissue Plasminogen Activator DRUG

0.25 mg TNK thrombolysis

TNK group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

Related Publications (1)

• Chen HS, Chen MR, Cui Y, Shen XY, Zhang H, Lu J, Zhao LW, Duan YJ, Li J, Wang YM, Min LQ, Zhao LH, Wan LS, Zhang ZH, Nguyen TN. Tenecteplase Plus Butyphthalide for Stroke Within 4.5-6 Hours of Onset (EXIT-BT): a Phase 2 Study. Transl Stroke Res. 2025 Jun;16(3):575-583. doi: 10.1007/s12975-024-01231-2. Epub 2024 Jan 19.

  PMID: 38238620 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TNK-tissue plasminogen activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 12, 2022
• Study Start: February 11, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 28, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)