Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window

ConditionStroke
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Hospital of China Medical University

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

Treatment groups

864 Participants
are divided into 2 treatment groups