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

NCT06010628 | Recruiting Phase 4 DMC

• 1 other identifier: Y (2023) 144
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 2

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Conditions

Stroke, Ischemic

Keywords

thrombolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• proportion of modified Rankin Scale (mRS) 0-2

  90±7 days

• ordinal distribution of modified Rankin Scale (mRS)

  90±7 days

• change in National Institute of Health stroke scale (NIHSS) score

  24 (-6/+12) hours

• change in National Institute of Health stroke scale (NIHSS) score

  10±2 days

• occurrence of early neurological improvement (ENI)

  24 (-6/+12) hours

Study Arms (2)

Tenecteplase group

EXPERIMENTAL

intravenous thrombolysis with tenecteplase

Drug: Tenecteplase

Control group

OTHER

standard stroke care based on national guideline

Drug: Tenecteplase

Interventions

Tenecteplase DRUG

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

Control group; Tenecteplase group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (2)

Hui-Sheng Chen

Shenyang, None Selected, 110840, China

RECRUITING

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (2)