Minor Ischemic Stroke Clinical Trial
Official title:
TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Multicenter, Prospective, Open Label, Blinded-endpoint, Randomized Controlled Trial
The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with measurable neurological deficit will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
The study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit will be enrolled. The measurable neurological deficit is defined as impairment of language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg. Control group (standard medical care): Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline. The primary endpoint is excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Completed |
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Phase 2 |