NCT07536165

Extended Time Window Intravenous Tenecteplase Thrombolysis Registry for Acute Ischemic Stroke

Extended Time Window Intravenous Tenecteplase Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-TNK Registry)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The EXTEND-TNK Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous tenecteplase administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.

Detailed description

This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous tenecteplase more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90±14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous tenecteplase, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.

Conditions

• Stroke
• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase	Intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) administered as a single IV bolus over 5-10 seconds. In this observational cohort, tenecteplase is the only thrombolytic agent included and there is no active comparator.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

2 sites across 1 country: China