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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase

Enrolling

Phase 4

Conditions

Stroke, Ischemic

Treatments

Drug: Tenecteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT06010628

Y (2023) 144

Details and patient eligibility

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Enrollment

1,440 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.