NCT05199662

Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT

A Phase III, Randomized, Multi-center Clinical Trial That Will Examine Whether Treatment With Intravenous TNK is Superior to Placebo in Patients Who Suffer a Non-large Vessel Occlusion Ischemic Stroke Within 4.5-12 Hours From Time Last Seen Well

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (estimated)
• Sponsor: Hospital Moinhos de Vento · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging.

Detailed description

Prospective, multi-center, randomized, controlled, double blinded trial. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging. Randomization will be done under a minimization process using age (≤70 vs. \>70 years), baseline NIHSS (≤10 vs. \>10), therapeutic window (4.5-9 or 9-12 hours after TLKW), randomization scenario and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. The total sample size is 466 participants (233 in each arm). Interim analysis is planned with 40% and 67% of the total sample, with the possibility of stopping due to efficacy or futility, in addition to an adaptive design based on the conditional probability of a positive result.

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
DRUG	Intravenous tenecteplase	Intravenous tenecteplase (TNK). Patients will receive intravenous TNK (0.25mg/kg, maximum 25mg, administered as a bolus over 5 seconds).
DRUG	Placebo	Placebo matching IV TNK

Timeline

• Start date: 2022-01-20
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2022-01-20
• Last updated: 2025-04-04

Locations

15 sites across 1 country: Brazil