A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial.

Abstract

Background:Almost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes, however, this benefit has not been seen with intravenous alteplase in published randomized trials.Design:TEMPO-2 (A Randomized Controlled Trial of tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25mg/kg) over non thrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with NIHSS <5 and visible arterial occlusion or perfusion deficit within 12 hours of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin Scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0-1, mRS 0-2, ordinal shift analysis of the mRS, partial and full recanalization on follow up CT Angiogram.Conclusion:Results of this trial will aid in determining whether there is benefit of using tenecteplase (0.25mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion.Trial Registry Name:A Randomized Controlled Trial of tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion, Registration number: NCT02398656; URL: https://clinicaltrials.gov/study/NCT02398656 .