About this trial
To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Eligibility criteria
Qualifiers
Male or female subjects (age ≥ 18 years).
Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
Disqualifiers
Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
History of stroke within the last 3 months.
History of intracranial hemorrhage.
Suspected subarachnoid hemorrhage.
Trial design
Treatments tested in this trial
- Tenecteplase (0.25mg/kg)
- Standard Medical Management