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

Phase 4

Recruiting

• Conditions: Stroke, Ischemic
• Interventions: Drug: Tenecteplase

• Registration Number: NCT06010628
• Lead Sponsor: General Hospital of Shenyang Military Region

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Study Start: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Tenecteplase	standard stroke care based on national guideline
Tenecteplase group	Tenecteplase	intravenous thrombolysis with tenecteplase

Primary Outcome Measures

Name	Time	Method
proportion of modified Rankin Scale (mRS) 0-1	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	90±7 days
intracranial hemorrhage	24 (-6/+12) hours	any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification
any bleeding event	24 (-6/+12) hours
ordinal distribution of modified Rankin Scale (mRS)	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
change in National Institute of Health stroke scale (NIHSS) score	10±2 days	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
occurrence of early neurological improvement (ENI)	24 (-6/+12) hours	ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
major systemic bleeding event	24 (-6/+12) hours
proportion of modified Rankin Scale (mRS) 0-2	90±7 days	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
symptomatic intracranial hemorrhage (sICH)	24 (-6/+12) hours	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.
new stroke or other vascular event(s)	90±7 days

Trial Locations

Locations (2)

Hui-Sheng Chen; 🇨🇳 ShenYang, None Selected, China

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China