NCT07475949

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.

Detailed description

UTOPIA is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) trial that aims to assess the efficacy and safety of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, selected by non-contrast CT. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. Participants randomized to the intervention group will receive intravenous tenecteplase at 0.25 mg/kg with a maximum dose of 25 mg and standard medical treatment, and those randomized to the control group will receive standard medical treatment only, without intravenous thrombolysis.

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, administered as soon as possible after the randomization.
OTHER	Standard medical treatment	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: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China