Using Tenecteplase for Stroke Treatment Between 4.5 to 6 Hours After Onset

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

This study is testing if a medication called tenecteplase can help people who have had a stroke between 4.5 to 6 hours after their symptoms started.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1440 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 2 sites (Shenyang, None Selected and 1 other locations)
• Trial ID: NCT06010628 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of intravenous tenecteplase (TNK) for patients experiencing acute ischemic stroke (AIS) within a time frame of 4.5 to 6 hours from symptom onset. The research aims to extend the current treatment window for thrombolysis, which is typically limited to 4.5 hours, by evaluating the outcomes of patients treated with TNK during this extended period. Participants will be assessed for eligibility based on specific criteria, including age, stroke confirmation via imaging, and neurological assessment. The study seeks to determine whether TNK can provide benefits in terms of safety and effectiveness for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an acute ischemic stroke within 4.5 to 6 hours of onset and meet specific neurological assessment criteria.

Not a fit: Patients with pre-stroke disabilities or contraindications to thrombolysis, such as recent head injuries or certain medical histories, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could expand the treatment window for thrombolysis in stroke patients, potentially improving outcomes for those who arrive at the hospital later.

How similar studies have performed: Previous pilot studies have suggested the safety and feasibility of extending the thrombolysis treatment window, indicating potential for success in this approach.

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.

Where this trial is running

Shenyang, None Selected and 1 other locations

• Hui-Sheng Chen — Shenyang, None Selected, China (Recruiting)
• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)

Conditions Stroke, Ischemic; thrombolysis