Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06010628

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

Led by General Hospital of Shenyang Military Region · Updated on 2025-08-21

1440

Participants Needed

2

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke confirmed by non-contrast CT and CTA for large vessel occlusion assessment
  • Time from last known well to treatment is between 4.5 and 6 hours
  • NIH Stroke Scale score of 4 or higher at randomization
  • First stroke or past stroke without significant neurological disability (mRS 0 or 1)
  • Researchers uncertain about the benefits and risks of thrombolysis
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Pre-stroke disability with mRS 2 or higher
  • Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criteria
  • Contraindications to thrombolysis including recent head injury or stroke within 3 months
  • History of intracranial hemorrhage or brain tumors
  • Intracranial or spinal surgery within 3 months
  • Recent myocardial infarction or major surgery
  • Recent gastrointestinal or urinary bleeding
  • Arterial puncture at noncompressible site within 7 days
  • Active internal bleeding or coagulation abnormalities
  • Aortic arch dissection
  • Heparin therapy within 24 hours
  • Infective endocarditis
  • Taking warfarin with INR greater than 1.6 or abnormal APTT
  • High blood pressure (systolic ≥185 mmHg or diastolic ≥110 mmHg)
  • Low blood glucose (less than 50 mg/dl)
  • Neurological deficit after epileptic seizures
  • Pregnancy
  • Allergy to study drugs
  • Serious other diseases
  • Participation in other clinical trials within 3 months
  • Deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Hui-Sheng Chen

Shenyang, None Selected, China, 110840

Actively Recruiting

2

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China, 110016

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here