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 (DIRECT-TNK)

NCT05199194 Phase 3 RECRUITING

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.

Details

Lead sponsor	Hospital Moinhos de Vento
Phase	Phase 3
Status	RECRUITING
Enrolment	398
Start date	2022-05-27
Completion	2027-07

Conditions

• Stroke, Ischemic
• Stroke, Acute

Interventions

• Tenecteplase
• Placebo

Primary outcomes

• Distribution of the modified Rankin Scale scores at 90 days — 90 days
  Distribution of the modified Rankin Scale scores (shift analysis).

Countries

Brazil