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NCT Number: NCT06010628

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hui-Sheng Chen, Shenyang, None Selected, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Pre-stroke disability (mRS≥2);
  • Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
  • 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;
  • Pregnancy;
  • Allergy to test drugs;
  • Comorbidity with other serious diseases;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for the study considered by researcher.

Treatment and study plan

Tenecteplase

Drug

intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).

Primary outcomes

  1. proportion of modified Rankin Scale (mRS) 0-1

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary outcomes

  1. proportion of modified Rankin Scale (mRS) 0-2

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  2. ordinal distribution of modified Rankin Scale (mRS)

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  3. change in National Institute of Health stroke scale (NIHSS) score

    Time frame: 24 (-6/+12) hours

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

  4. change in National Institute of Health stroke scale (NIHSS) score

    Time frame: 10±2 days

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.

  5. occurrence of early neurological improvement (ENI)

    Time frame: 24 (-6/+12) hours

    ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score

  6. new stroke or other vascular event(s)

    Time frame: 90±7 days

  7. all-cause mortality

    Time frame: 90±7 days

  8. symptomatic intracranial hemorrhage (sICH)

    Time frame: 24 (-6/+12) hours

    sICH is defined as parenchymal hematoma type 1 or 2 (PH1 or PH2), remote intraparenchymal hematoma (RIH), subarachnoid hemorrhage, or intraventricular hemorrhage on head CT/MRI scan causally associated with clinically significant neurological deterioration (NIHSS score ≥4 point increase) in the opinion of the clinical investigator or independent safety monitor.

  9. intracranial hemorrhage

    Time frame: 24 (-6/+12) hours

    any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification

  10. major systemic bleeding event

    Time frame: 24 (-6/+12) hours

  11. any bleeding event

    Time frame: 24 (-6/+12) hours

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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