NCT06559436

Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke

Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke-a Randomised, Controlled, Multicentre Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.

Detailed description

Previous study has confirmed that in acute ischemic stroke patients with large vessel occlusion within 4.5-24 hours of symptom onset and a salvageable penumbra on perfusion imaging, TNK thrombolysis is safe and can significantly improve the prognosis in the absence of mechanical thrombectomy. However, it is currently unknown whether TNK intravenous thrombolysis beyond optimal time window can improve the prognosis of distal Medium Vessel Occlusion (MeVO) related patients.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Intravenous thrombolysis	Patients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg,
OTHER	Standard medical management	Standard medical management

Timeline

• Start date: 2024-10-02
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2024-08-19
• Last updated: 2024-10-24

Locations

1 site across 1 country: China