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

Phase 2 Completed 100 enrolled General Hospital of Shenyang Military Region

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2022-02-11
Primary completion: 2022-09-30
Completion: 2022-12-28

Outcome

Missed primary endpoint

paper sICH occurred in 2.0% (1/50) in TNK group and 0.0% (0/49) in control group with no difference (unadjusted P = 0.998). PMID 38238620 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	0.25 mg/kg	Intravenous