Clinical trial NCT06010628: Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stroke, Ischemic
Keywords: thrombolysis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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


Eligibility criteria: 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.

Primary outcomes:
measure: proportion of modified Rankin Scale (mRS) 0-1
timeFrame: 90±7 days
Secondary outcomes:
measure: proportion of modified Rankin Scale (mRS) 0-2
timeFrame: 90±7 days
measure: ordinal distribution of modified Rankin Scale (mRS)
timeFrame: 90±7 days
measure: change in National Institute of Health stroke scale (NIHSS) score
timeFrame: 24 (-6/+12) hours
measure: change in National Institute of Health stroke scale (NIHSS) score
timeFrame: 10±2 days
measure: occurrence of early neurological improvement (ENI)
timeFrame: 24 (-6/+12) hours
measure: new stroke or other vascular event(s)
timeFrame: 90±7 days
measure: all-cause mortality
timeFrame: 90±7 days
measure: symptomatic intracranial hemorrhage (sICH)
timeFrame: 24 (-6/+12) hours
measure: intracranial hemorrhage
timeFrame: 24 (-6/+12) hours
measure: major systemic bleeding event
timeFrame: 24 (-6/+12) hours
measure: any bleeding event
timeFrame: 24 (-6/+12) hours
Other outcomes:
Locations:
city: ShenYang
country: China
facility: Hui-Sheng Chen
state: None Selected
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: