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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: TNK-Tissue Plasminogen Activator

Study type: Interventional

Funder types: Other

Identifiers

NCT05189509

y (2021) 110

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

TNK group

Experimental group

Description:

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

Treatment:

Drug: TNK-Tissue Plasminogen Activator

control group

Placebo Comparator group

Treatment:

Drug: TNK-Tissue Plasminogen Activator