NCT07475936

Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 392 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.

Detailed description

The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.

Conditions

• Acute Ischemic Stroke
• Tenecteplase

Interventions

Type	Name	Description
DRUG	Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)	Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.
OTHER	Standard medical care	Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China