drugset / Trial / NCT05624190

Intra-arterial Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Large Vascular Occlusion After Successful Mechanical Thrombectomy Recanalization

NCT05624190

Phase 4 Unknown 256 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to evaluate whether intra-arterial (IA) rhTNK-tPA thrombolysis can improve neurological outcomes in acute large vessel occlusion patients after successful mechanical thrombectomy (MT) recanalization between 4.5- 24 hours from symptom onset. Participants enrolled will be randomly assigned to study or control arm with a 1:1ratio. Study group will receive IA rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus best medical management, and control receive best medical management alone.

Timeline

Start
2023-02-16
Primary completion
2024-07
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenecteplase Protein / enzyme biologic 0.125 mg/kg Other

Indications