Status:
RECRUITING
Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Unpublished pilot EXIT-BT (EXte...
Eligibility Criteria
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);
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT06010628
Start Date
February 1 2024
End Date
December 15 2026
Last Update
August 21 2025
Active Locations (2)
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1
Hui-Sheng Chen
Shenyang, None Selected, China, 110840
2
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016