Tenecteplase Tested for Stroke Treatment Between 4.5 and 6 Hours
Tests tenecteplase, a clot-dissolving drug, in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Key facts
- Where
- Shenyang, ChinaSee the 2 sites
- Phase
- Phase 4
Where in China
- Department of Neurology, General Hospital of Northern Theater CommandShenyang, ChinaTaking people
- Hui-Sheng ChenShenyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- General Hospital of Shenyang Military Region
- Trial code
- NCT06010628
- Record updated
- 10 September 2026
- Original description
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.Read full original descriptionShow less
Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Inclusion: Age ≥ 18 year; Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators; The time from last known well to treatment: 4.5 - 6 hours; NIHSS ≥ 4 at randomization; First stroke onset or past stroke without obvious neurological deficit (mRS≤1); Uncertainty over the benefits and risks of thrombolysis by researcher; Signed informed consent.
Exclusion: Pre-stroke disability (mRS≥2); Allergy to test drugs; Comorbidity with other serious diseases; Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of <100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose < 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures; Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion; Pregnancy; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.