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

Phase 4RecruitingNCT06010628

General Hospital of Shenyang Military Region1,440 enrolled

Overview

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,440

Conditions

Stroke, Ischemic

Interventions

Tenecteplase

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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

new stroke or other vascular event(s)

Time frame: 90±7 days

all-cause mortality

Time frame: 90±7 days

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

intracranial hemorrhage

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

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

major systemic bleeding event

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

any bleeding event

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes