drugset / Trial / NCT05199662
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
Phase 3
Recruiting
466 enrolled
Hospital Moinhos de Vento
Boehringer Ingelheim · collabBrainomix Limited · collabMinistry of Health, Brazil · collabiSchemaView, Inc · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-01-20
- Primary completion
- 2026-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenecteplase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |