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RECRUITING
NCT05199194
PHASE3

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

Sponsor: Hospital Moinhos de Vento

View on ClinicalTrials.gov

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.

Official title: Randomization to EndoVascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Acute Ischemic Stroke Due to Large Intracranial VEssel OcclusioN Trial - DIRECT Thrombectomy vs. Intravenous TNK Plus Thrombectomy

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

398

Start Date

2022-05-27

Completion Date

2027-07

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

Tenecteplase

Intravenous thrombolysis with tenecteplase 0.25mg/kg

DRUG

Placebo

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

Locations (13)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clínicas Botucatu

Botucatu, Brazil

Hospital de Base do Distrito Federal

Brasília, Brazil

Hospital das Clínicas da UFPR

Curitiba, Brazil

Hospital Geral de Fortaleza

Fortaleza, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, Brazil

Hospital de Base de Rio Preto

São José do Rio Preto, Brazil

Hospital das Clínicas de São Paulo

São Paulo, Brazil

Hospital Sao Paulo

São Paulo, Brazil

Santa Casa de Misericordia de Sao Paulo

São Paulo, Brazil

Hospital Universitário de Uberlândia

Uberlândia, Brazil

Hospital Estadual Central

Vitória, Brazil