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Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke

NCT05199194 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2025-04-04

No results posted yet for this study

Summary

A phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial that will examine two strategies for the treatment of acute ischemic stroke associated with a large vessel anterior occlusion within 4.5 hours from symptoms onset: direct endovascular treatment vs. endovascular treatment preceded by intravenous tenecteplase.

Conditions

  • Stroke, Ischemic
  • Stroke, Acute

Interventions

DRUG

Tenecteplase

Intravenous thrombolysis with tenecteplase 0.25mg/kg

DRUG

Placebo

Intravenous administration of placebo, matching the volume of tenecteplase 0.25mg/kg

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Octavio M Pontes-Neto, MD, PhD · Hospital de Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

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

  • Raul G Nogueira, MD · University of Pittsburgh Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT05199194 on ClinicalTrials.gov