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

Stroke, Ischemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010628
• Other study ID #: Y (2023) 144
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: January 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 year
• Acute ischemic stroke confirmed by non-contrast computed tomography;
• 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);
• 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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Tenecteplase
intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang
China	Hui-Sheng Chen	ShenYang	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90±7 days
Secondary	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	90±7 days
Secondary	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	90±7 days
Secondary	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.	24 (-6/+12) hours
Secondary	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.	10±2 days
Secondary	occurrence of early neurological improvement (ENI)	ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score	24 (-6/+12) hours
Secondary	new stroke or other vascular event(s)		90±7 days
Secondary	all-cause mortality		90±7 days
Secondary	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.	24 (-6/+12) hours
Secondary	intracranial hemorrhage	any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification	24 (-6/+12) hours
Secondary	major systemic bleeding event		24 (-6/+12) hours
Secondary	any bleeding event		24 (-6/+12) hours