NCT07294209

Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients

Efficacy and Safety of Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients: A Prospective, Multicenter, Randomized Controlled Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 798 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The DATE-AGING study is a prospective, multicenter, randomized controlled trial investigating low-dose tenecteplase in elderly patients with acute ischemic stroke. Its primary objective is to evaluate the safety and efficacy of low-dose tenecteplase in elderly patients within 4.5 hours of acute ischemic stroke onset.

Conditions

• Acute Ischemic Stroke Patients

Interventions

Type	Name	Description
DRUG	low-dose tenecteplase intravenous thrombolysis	Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the low-dose group received tenecteplase (0.175 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 17.5 mg/patient.
DRUG	standard-dose tenecteplase intravenous thrombolysis	Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the standard-dose group received tenecteplase (0.25 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 25 mg/patient.

Timeline

• Start date: 2025-12-19
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-12-19
• Last updated: 2026-03-24

Locations

48 sites across 1 country: China