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

NCT05199662 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Ischemic Stroke, Acute

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Brainomix Limited

    collaborator INDUSTRY

  • iSchemaView, Inc

    collaborator UNKNOWN

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Gisele Sampaio Silva, MD, MPH, PhD · Universidade Federal de São Paulo

  • Raul G Nogueira, MD · Emory University

  • Sheila CO Martins, MD, PhD · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199662 on ClinicalTrials.gov