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RecruitingNCT06010628Updated Sep 10, 2026

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

A Phase 4 interventional study of Tenecteplase in Stroke, Ischemic, sponsored by General Hospital of Shenyang Military Region. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by General Hospital of Shenyang Military Region · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
1,440
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

02

Conditions studied

  • Stroke, Ischemic

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Keywords

  • thrombolysis
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's planned enrollment of 1,440 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,440 participants (estimated)

Study arms

  • Experimental
    Tenecteplase group

    intravenous thrombolysis with tenecteplase

    Drug: Tenecteplase

  • Other
    Control group

    standard stroke care based on national guideline

    Drug: Tenecteplase

Interventions

  • DrugTenecteplase

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 90±7 days

Secondary outcomes

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

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

    Time frame: 90±7 days

  2. ordinal distribution of modified Rankin Scale (mRS)

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

    Time frame: 90±7 days

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

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

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

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

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

    Time frame: 10±2 days

  5. occurrence of early neurological improvement (ENI)

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

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

  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)

    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.

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

  9. intracranial hemorrhage

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

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

  10. major systemic bleeding event

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

  11. any bleeding event

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

07

Study locations

2 of 2 sites recruiting
  • Hui-Sheng Chen
    Shenyang, None Selected 110840, China
    Recruiting
  • Department of Neurology, General Hospital of Northern Theater Command
    Shenyang, 110016, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06010628
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Director, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Aug 24, 2023
Start date
Feb 1, 2024
Primary completion
Dec 15, 2029 (estimated)
Completion
Dec 15, 2029 (estimated)
Last update
Sep 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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