Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlu
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 Te
| Condition(s) | Ischemic Stroke, Acute |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset \>4.5 hours and is ineligible for endovascular treatment under standard of care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and dominant M2 segments, and vertebrobasilar arteries). \* Dominant M2 segment is defined is a division supplying \>50% of the MCA territory vs co-dominant supplying 50% of the MCA territory vs non-dominant supplying \<50% of the MCA territory. 2. No significant pre-stroke functional disability (mRS ≤2). 3. Age ≥18 years (no upper age limit). 4. Clinical or imaging mismatch evidence in distal artery territories, defined as one of the following scenarios (A, B or C): * Scenario A - all of the following: * S |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hospital Moinhos de Vento |
| Locations | Porto Alegre, Rio Grande do Sul, Brazil; Botucatu, Brazil; Campinas, Brazil; Campo Grande, Brazil; Curitiba, Brazil; Fortaleza, Brazil (+9 more sites) |
| Start date | 2022-01-20 |
| NCT ID | NCT05199662 |
| Official listing | https://clinicaltrials.gov/study/NCT05199662 |