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

NCT ID: NCT05189509

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2022-12-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNK group

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

Group Type: EXPERIMENTAL

TNK-Tissue Plasminogen Activator

Intervention Type: DRUG

0.25 mg TNK thrombolysis

control group

Group Type: PLACEBO_COMPARATOR

TNK-Tissue Plasminogen Activator

Intervention Type: DRUG

0.25 mg TNK thrombolysis

Interventions

TNK-Tissue Plasminogen Activator

0.25 mg TNK thrombolysis

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38238620 (View on PubMed)

Other Identifiers

y (2021) 110

Identifier Type: -

Identifier Source: org_study_id