Clinical Trial

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

Study acronym: DIRECT-TNK
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated April 4, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-01-06; most recent amendment 2025-04-02.
Status change: Not Yet Recruiting → Recruiting 2022-04-18
Trial Details
NCT Number NCT05199194
Lead Sponsor Hospital Moinhos de Vento
Collaborators: Ministry of Health, Brazil, Boehringer Ingelheim, Medtronic
Conditions Stroke, Ischemic, Stroke, Acute
Enrollment 398 participants
Start Date 2022-05-27
Primary Completion 2026-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-04