Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion Wi… (NCT05199662) | Clinical Trial Compass
RecruitingPhase 3
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
Brazil466 participantsStarted 2022-01-20
Plain-language 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
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. No significant pre-stroke functional disability (mRS ≤2).
✓. Age ≥18 years (no upper age limit).
✓. Clinical or imaging mismatch evidence in distal artery territories, defined as one of the following scenarios (A, B or C):
✓. Patient treatable within 4.5-12 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as initiation of IV TNK or placebo infusion.
✓. Informed consent obtained from patient or acceptable patient surrogate.
Exclusion criteria
✕. Intracranial hemorrhage (ICH) identified by CT or MRI.
✕. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient without eligibility criteria.
What they're measuring
1
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days