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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a new ischemic stroke who can be treated 4.5 to 6 hours after they were last known to be well. It tests tenecteplase given into a vein.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke confirmed by CT scan, with a stroke severity score (NIHSS) of 4 or more. First stroke, or an earlier stroke with no obvious lasting problems (mRS of 1 or less).
- Earlier treatment
- No clot-dissolving treatment already planned based on the WAKE-UP or EXTEND study criteria. No heparin within 24 hours. No other clinical trial within 3 months.
Main reasons for not taking part
- Disability before the stroke (mRS of 2 or more)
- Any reason that rules out clot-dissolving treatment, such as bleeding in the head, a recent stroke or head injury, or recent major surgery
- Blood pressure of 185 mmHg or more (systolic) or 110 mmHg or more (diastolic)
- Pregnancy
- Allergy to the test drugs
Read by machine on 9 November 2026.
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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.