drugset / Trial / NCT06954155

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

NCT06954155

Phase 3 Recruiting 330 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).

Timeline

Start
2025-05-30
Primary completion
2027-02-28
Completion
2027-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenecteplase Protein / enzyme biologic 0.25 mg/kg Intravenous
Comparator Aspirin Small molecule
Comparator Clopidogrel Small molecule

Indications